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AMRI - Analytical and Solid State Services

Albany, NY, US

AMRI is a global contract research and manufacturing organization that has been working with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, we provide a complete suite of capabilities in drug discovery, development and manufacturing. We’ve got it down to an exact science.

We care about the quality and success of your projects as if they were our own. No matter the size of your project or the complexity of the challenge, our experts pinpoint and execute the precise solution to hit your target. From molecule to molecule, batch to batch, your product will benefit from our ingenuity.

Analytical and Solid State Services

Ensure compound, product and packaging attributes while mitigating downstream risk in manufacturing. We offer global end to end solutions from cGMP analytical testing services of both small and... Show more »

AMRI is a global contract research and manufacturing organization that has been working with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, we provide a complete suite of capabilities in drug discovery, development and manufacturing. We’ve got it down to an exact science.

We care about the quality and success of your projects as if they were our own. No matter the size of your project or the complexity of the challenge, our experts pinpoint and execute the precise solution to hit your target. From molecule to molecule, batch to batch, your product will benefit from our ingenuity.

Analytical and Solid State Services

Ensure compound, product and packaging attributes while mitigating downstream risk in manufacturing. We offer global end to end solutions from cGMP analytical testing services of both small and large molecules, solid-state chemistry and particle engineering, to container qualification and testing, packaging and distribution testing, medical device and drug delivery testing, extractables/leachables and impurities detection and microbiology. Development and validation of test methods is routinely executed by our experienced teams to meet your batch release, stability and quality control testing needs.

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AMRI - Analytical and Solid State Services has not listed any services.

Spray Drying
Price on request
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Package and Container Testing
Price on request

Container Closure Integrity - Electrical Conductivity - High Voltage Leak Detection (HVLD)

We conduct electrical conductivity / high voltage leak detection (HVLD) testing on a range of package systems, including parenteral vials, prefilled cartridges and syringes, plastic containers and plastic bags or pouches.

HVLD... Show more »

Container Closure Integrity - Electrical Conductivity - High Voltage Leak Detection (HVLD)

We conduct electrical conductivity / high voltage leak detection (HVLD) testing on a range of package systems, including parenteral vials, prefilled cartridges and syringes, plastic containers and plastic bags or pouches.

HVLD testing can detect the presence of a leak and potentially its location in the wall of a nonporous package (whether rigid or flexible) that contains liquid product. This is because when a leak path occurs near an electrically conductive liquid, the electrical resistance will drop in the test sample, as evidenced by a spike in the current above the predetermined pass/fail limit.

This highly sensitive method even works to detect package defects such as clogs by product formulation proteins or salts. Stability studies support the use of this technology for nondestructive leak testing for a variety of product formulation types.

Container Testing

Operating a Container Testing Center of Excellence as a separate and distinct business unit, we provide an experienced and highly qualified team of chemists, engineers and laboratory technicians who are solely dedicated to FDA-regulated container and package testing. The entire team is well versed in all relevant regulatory test procedures under USP, EP, JP, CFR and ASTM methodologies. We perform many of the qualification tests on a daily or weekly basis.

Under the direction of our quality assurance department, we stay current on both procedural and test method revisions through a strict schedule of training and retraining. Our experts bring both scientific expertise and leading technology to their assessments of a variety of containers and range of composition materials for numerous package systems.

We work closely with you to determine the proper tests to perform and ensure that you meet the strict regulatory requirements for your product-holding system.

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Packaging, Form/Fill/Seal
Price on request

Our expert team offers parenteral vial capping and residual seal force (RSF) testing of parenteral package systems. When we apply RSF testing in conjunction with leak test methods such as helium leak detection or vacuum decay testing, we can determine an optimal range of residual seal force values that correlate with a reduced... Show more »

Our expert team offers parenteral vial capping and residual seal force (RSF) testing of parenteral package systems. When we apply RSF testing in conjunction with leak test methods such as helium leak detection or vacuum decay testing, we can determine an optimal range of residual seal force values that correlate with a reduced risk of leakage resulting from improper capping force.

Residual seal force is not a leak test but an indirect measure of the compressive force exerted by the stopper on the vial’s land surface. Genesis staff operate a Genesis Westcapper RW50 in our laboratory to apply closures at a range of compressive forces. We monitor the vial’s resistance to compression to gain an objective measure of residual seal force.

A quality seal requires an optimal amount of compressive force during the capping process. Insufficient force may result in leakage, and excessive force may result in cracking and bulging. Both risk the integrity of the closure system. RSF testing is especially valuable if your objective is to establish optimal sealing parameters or implement a sampling procedure during product production.

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Bioburden Testing
Price on request

We perform bioburden/microbial enumeration testing (MET) on various pharmaceutical articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products. MET includes assessment of the physical characteristics and inherent... Show more »

We perform bioburden/microbial enumeration testing (MET) on various pharmaceutical articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products. MET includes assessment of the physical characteristics and inherent antimicrobial properties of the product in question.

Bioburden testing ensures that pre-sterilization microbial load is within the tolerance of the sterilization cycle, residuals after sterilization are at acceptable levels and products are properly sterilized throughout the program. Bioburden testing is also used during the release of a product to market in order to demonstrate that the manufacturing process remains in control. This testing includes enumeration by total aerobic microbial count and total yeast and mold count.

Regulatory bodies require monitoring of the bioburden load in products used for humans and animals to ensure product safety according to procedures outlined USP <61> and <62> guidances:

  • USP <61> An enumeration test, sometimes referred to as bioburden, that quantifies microorganisms in nonsterile products or raw materials
  • USP <62> Testing for the presence or absence of specific organisms in a product, which can include Escherichia coli, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species, Clostridia species and bile tolerant gram negative bacteria

USP <61> and USP <62> testing provides harmonization to the European Pharmacopeia methods for testing nonsterile pharmaceuticals.

To conduct bioburden testing, we apply the following techniques:

  • Membrane filtration method
  • Standard plate count
  • Pour plate method
  • Most probable number
  • Direct enrichment Membrane filtration enrichment
  • Microbiological Population Verification
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Toxicology Risk Assessment
Price on request

TOXICOLOGICAL RISK ASSESSMENT (TRA)

Determine if your container, closure, device or material is suitable for use through an evaluation of toxicological impact. We offer toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests,... Show more »

TOXICOLOGICAL RISK ASSESSMENT (TRA)

Determine if your container, closure, device or material is suitable for use through an evaluation of toxicological impact. We offer toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means. This information allows you to mitigate risk during product development and demonstrate safety in regulatory documentation.

Our complete suite of TRA services includes:

  • Estimation of risk from extractables and leachables compounds from container, closure and drug delivery systems
  • Determination of PDEs, ADIs and margins of safety from process impurities, residual solvents, degradants and other source materials
  • Packaging compliance guidance and product labeling reviews
  • Determination of biocompatibility and/or suitability
  • Assessment of material vendor, supplier and manufacturer changes (change control)
  • Consideration of potential for misuse of the product (failure analysis)
  • Additional testing if necessary to determine risk of chemical profile

Quality Risk Assessment is recommended by regulatory body. AMRI has the technical expertise and resource to guide customer to navigate through the complex assessment process.

  • Extractable/LeachableProfileToxRiskAssessment(TRA)
  • GenotoxicImpurityRiskAssessmentandManagementICH(M7)
  • ElementalImpurityRiskAssessmentICH(Q3D)
  • EstablishmentofAllowableLeachableSubstances(ISO10993-17)
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Drug Formulation Evaluation
Price on request

FORMULATION SERVICES
Drug Product Development and Delivery

Leveraging an understanding of solid state properties gained from API solid form screening and characterization, our scientists provide support and direction to design robust formulations for preclinical and clinical use. Our teams work closely together or with... Show more »

FORMULATION SERVICES
Drug Product Development and Delivery

Leveraging an understanding of solid state properties gained from API solid form screening and characterization, our scientists provide support and direction to design robust formulations for preclinical and clinical use. Our teams work closely together or with external providers to transfer knowledge and support drug product manufacture and scale-up activities of unit operations, including granulation, blending, milling, compression or preparation of solutions and semi-solids.

Excipient Compatibility

An unexpected interaction that affects the chemical or physical properties of the API or another critical component in the formulation can be deleterious to the development of a drug. These stability problems often lead to formulation changes that can require bridging studies, ultimately resulting in increased time to market. Our excipient compatibility studies save both time and cost by assessing the risk of excipient interactions prior to formulation development. We characterize the resulting materials to determine changes in both chemical and physical properties.

Enabling Poorly Water-Soluble Compounds

Our approaches to enable preclinical and early clinical evaluation of APIs with poor water solubility characteristics include supersaturated solutions and amorphous solid dispersions. Our scientists apply increasing solution concentration (or useful supersaturation) in aqueous formulations to identify suitable excipient combinations at varied concentrations and temperatures. We monitor physical stability to assess how effective excipients can inhibit crystallization. Based on these results, we conduct further experiments using a concentration gradient of the API and the most promising formulations from the initial study. Our experts then conduct scale-up of lead candidate formulations and determine thermodynamic solubility with respect to the API (or hydrate, if known).

A poorly water-soluble API processed with materials, such as polymers, can result in molecular dispersions where the API is embedded in a polymer matrix in a highly disordered or amorphous phase. We conduct screening for amorphous solid dispersions using manual experiments, where the particular combination of methods used — including spray drying, rotary evaporation and lyophilization — is determined based on the properties of the API and other excipients used in the composition. Given the importance of maintaining physical stability in the solid state and upon exposure to aqueous media, we conduct rigorous stress studies under various conditions to look for deliquescence and crystallization and in aqueous solutions to look for evidence of crystallization.

Given that the intended purpose of amorphous solid dispersions is to overcome the poor water solubility of the API, we conduct dissolution testing in both aqueous formulation buffers and biorelevant media over the relevant physiological pH range as criteria for amorphous solid dispersion candidate selection. We have developed test methods with the knowledge that the solid may not fully dissolve and that sink conditions will not be achieved in the GI tract, due in part to the distribution in the fluid volumes in vivo.

Upon identification of a composition with desired performance attributes, our scientists continue to support you through development. These activities can include development of reconstitution instructions for preparing an aqueous suspension for preclinical use all the way to dosage form development containing the amorphous solid dispersion.

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Energy Dispersive Spectroscopy
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MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Energy dispersive spectrometry (EDS) combines the advantages of scanning electron microscopy (SEM) and elemental analysis. Samples examined by SEM can be analyzed for elemental content by EDS under similar conditions of magnification and sampling environment. Each point represents an area as small as 1 Å.

MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Energy dispersive spectrometry (EDS) combines the advantages of scanning electron microscopy (SEM) and elemental analysis. Samples examined by SEM can be analyzed for elemental content by EDS under similar conditions of magnification and sampling environment. Each point represents an area as small as 1 Å.

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Shelf Life Testing
Price on request

We perform accelerated aging (AA) on materials, products and packaging systems, including packaged medical devices, to provide a lens into real-time shelf life. We conduct both accelerated aging and real-time (RT) aging for your pharmaceutical, biotech, medical device and consumer product packaging.

AA conditioning, based on... Show more »

We perform accelerated aging (AA) on materials, products and packaging systems, including packaged medical devices, to provide a lens into real-time shelf life. We conduct both accelerated aging and real-time (RT) aging for your pharmaceutical, biotech, medical device and consumer product packaging.

AA conditioning, based on the Q10 theory of ASTM F1980, allows you to evaluate your package system performance. We maintain a series of qualified test chambers to assist you in evaluating and defining shelf life claims in a fraction of the time. Additionally, we offer RT aging programs and storage at typical conditions in a single integrated laboratory.

Our high-performance Cincinnati Sub-Zero environmental chambers accommodate a complete suite of storage capabilities and testing programs:

  • -30°C to +60°C walk-in environmental chamber for sterile barrier systems
  • +23°C ± 1°C /50% RH ± 2% walk-in environmental chamber for real-time/controlled environment
  • Reach-in and bench-top chambers with capabilities from -20°C to +170°C for developmental studies
  • +5°C ± 3°C ICH refrigerated long-term storage
  • +25°C ± 2°C /60% RH ± 5% ICH long-term/accelerated (refrigerated)
  • +30°C ± 2°C /65% RH ± 5% ICH intermediate (Zones I, II, III and IVa)
  • +30°C ± 2°C /75% RH ± 5% ICH long-term (Zone IVb)
  • +40°C ± 2°C /75% RH ± 5% ICH accelerated (Zones I–IV)
  • -20°C ± 5°C ICH long-term (frozen) -70°C through -90°C cryogenic storage
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FT-IR
Fourier transform infrared spectroscopy
Price on request

MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Fourier transform infrared spectroscopy (FTIR) is a methodology for chemical and structural analysis of organic products, providing a unique “fingerprint” spectrum of each molecule. The resulting spectrum can identify subtle changes in the chemical or... Show more »

MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Fourier transform infrared spectroscopy (FTIR) is a methodology for chemical and structural analysis of organic products, providing a unique “fingerprint” spectrum of each molecule. The resulting spectrum can identify subtle changes in the chemical or physical properties of the sample. Each FTIR spectrum represents an area of the sample as small as 10 µm, and distribution of a single component is easily visualized. With proper selection of conditions, FTIR can overcome limitations of Raman and NIR.

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Imaging & Spectroscopy
Price on request

MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Imaging is a general term for collection (usually automated) and analysis of data from a large number of locations on a sample. We employ two common methods of collecting data: use of an array detector, where data for the entire image are collected... Show more »

MAPPING AND IMAGING STUDIES
Drug Product Development and Delivery

Imaging is a general term for collection (usually automated) and analysis of data from a large number of locations on a sample. We employ two common methods of collecting data: use of an array detector, where data for the entire image are collected simultaneously, and automated mapping, in which analysis is carried out on multiple discrete points. Our scientists can observe small particles or domains that would not be resolved with a single analysis of the entire area. Investigation of interfacial interactions is possible by observing differences between adjacent pixels. We can process the array repeatedly, observing different chemical or physical signatures.

Imaging over a large area provides a more representative analysis of the sample for quantitative applications. Each pixel of the image provides a full spectrum that our scientists can compare to spectral databases of known compounds for specific identification. Trace particles can thus provide a pure spectrum of a contaminant. Individual spectra from each pixel allow quantitative distribution within the area analyzed.

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Packaging, Labels
Price on request

We can evaluate your pharmaceutical and medical device product labels for legibility and adhesion properties through temperature and humidity exposure of applied labels, peel resistance and abrasion resistance.

Our suite of testing methods includes:

  • ASTM D6252, Peel Adhesion of Pressure-Sensitive Label Stocks at a 90°... Show more »

We can evaluate your pharmaceutical and medical device product labels for legibility and adhesion properties through temperature and humidity exposure of applied labels, peel resistance and abrasion resistance.

Our suite of testing methods includes:

  • ASTM D6252, Peel Adhesion of Pressure-Sensitive Label Stocks at a 90° Angle
  • ASTM D6862, 90 Degree Peel Resistance of Adhesives
  • ASTM D3330, Peel Adhesion of Pressure-Sensitive Tape
  • ASTM D2979, Pressure-Sensitive Tack of Adhesives Using an Inverted Probe Machine
  • ASTM D6195, Loop Tack FINAT Methods, Numbers 1–9
  • ASTM D5264, Abrasion Resistance of Printed Materials by the Sutherland Rub Tester PSTC Methods Attribute
  • Inspections Over Time

Barcode Quality Testing Services

To manage the risk associated with poor barcode performance, our testing services can optimize your in-house barcode printing operation, prequalify a new vendor for barcode printing or help a long-time vendor to improve the barcodes it produces for you.

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Process Analytical Technology Consulting
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PROCESS ANALYTICAL TECHNOLOGY AND PHARMACEUTICAL QUALITY BY DESIGN

Process analytical technology (PAT) is a system for designing, analyzing and controlling manufacturing processes based on an understanding of the scientific and engineering principles involved and identification of the variables that affect product quality. The... Show more »

PROCESS ANALYTICAL TECHNOLOGY AND PHARMACEUTICAL QUALITY BY DESIGN

Process analytical technology (PAT) is a system for designing, analyzing and controlling manufacturing processes based on an understanding of the scientific and engineering principles involved and identification of the variables that affect product quality. The primary goal of PAT is to provide processes that consistently generate products of predetermined quality.

Our PAT approach is consistent with the FDA perspective that quality cannot be tested into products, but should be built in. We achieve improved quality and efficiency through:

  • Reduction of cycle times using on-, in- or at-line measurements and controls
  • Prevention of reject product and waste
  • Real-time product release Increased use of automation
  • Facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity
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Computational Modeling
Price on request

Our computational scientists can derive more information than you ever thought possible from laboratory X-ray powder patterns. We have developed the first software capable of rapidly providing accurate structural information from standard laboratory X-ray powder diffraction (XRPD) data.

Our software enables us to quickly obtain... Show more »

Our computational scientists can derive more information than you ever thought possible from laboratory X-ray powder patterns. We have developed the first software capable of rapidly providing accurate structural information from standard laboratory X-ray powder diffraction (XRPD) data.

Our software enables us to quickly obtain structural information such as correct unit cell parameters, molecular packing information and electron density distribution within the unit cell. Leverage this information to speed your drug development and address manufacturing issues for your drug substance and drug product.

Information From XRPD Data

  • Unit cell parameters, molecular packing and electron density distribution
  • Prediction of density, stability, hygroscopicity and other properties
  • Analysis of microstructure, average crystal size and strain
  • Analysis of X-ray amorphous materials and determination of their crystalline parents
  • Distinction between true amorphous and disordered crystalline materials
  • Quantitative (cGMP) and semi-quantitative (non-GMP) mixture analysis
  • Custom Development Services

We offer project-based custom software development and analytical instrumentation improvement in our areas of expertise, including automation, XRPD and Raman. Our scientists help you get the most out of your existing X-ray diffraction systems by improving data quality and productivity.

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Protein Crystallization
Price on request

CRYSTALLIZATION PROCESS DEVELOPMENT
Solid-State Chemistry and Particle Engineering

Our dedicated group of crystallization experts has a legacy of success in particle engineering and technology transfer. Experienced scientists and engineers offer a fit-for-purpose approach to crystallization processes adapted for each... Show more »

CRYSTALLIZATION PROCESS DEVELOPMENT
Solid-State Chemistry and Particle Engineering

Our dedicated group of crystallization experts has a legacy of success in particle engineering and technology transfer. Experienced scientists and engineers offer a fit-for-purpose approach to crystallization processes adapted for each stage of pharmaceutical development. We take a quality by design approach to crystallization process development, aiming for the consistent preparation of batches with the desired purity, crystal form and particle properties. We enable reproducible and streamlined downstream processes, including filtration, drying, transfer and storage of the bulk drug substance, as well as critical performance attributes for drug product formulation and manufacturing.

Design of Crystallization Process

Solid form understanding and preliminary solubility data must be gathered to identify possible crystallization techniques and solvent systems for the design of a scalable process. Standard solution crystallization techniques include cooling, antisolvent addition, pH swing, reaction and evaporation. We collect metastable zone width information in systems of interest to determine suitable seeding conditions and control strategy. Online and offline monitoring during crystallization may also provide valuable insight into nucleation and growth of the crystals as well as the polymorphic form. Our scientists have access to specialized equipment for crystallization process development, including controlled laboratory reactors from 50 mL to 2 L, equipment for solubility and metastable zone width determination and in situ or at-line monitoring of crystal form, supersaturation, nucleation, particle size and morphology.

Process Analytical Technology and Quality by Design

Our scientists have access to process analytical technology equipment to allow development and optimization of crystallization using a quality by design approach:

Solubility determination capability
- Crystal16™ Solvent addition Gravimetric Equilibrium solubility with analysis of supernatant by UV-vis, HPLC or UPLC
- Controlled laboratory reactors from 50 mL to 2 L scale
- Mettler Toledo EasyMax™ controlled lab reactors (50–100 mL) Radleys Lara™ (100, 250, 500 mL, 1 L and 2 L)

In situ and offline monitoring
- pH
- Mettler Toledo
- Turbidity Trb 8300
- Kaiser Raman RXN3
- Image analysis

Filtration
- Vacuum filtration
- Agitated filter dryer (up to 2 L scale)
- Centrifuge

Crystallization Optimization

We can design, optimize or troubleshoot your crystallization process for product purity, recovery or solids separation and isolation. Our experts provide you with an understanding of your process to reduce operational problems by means of:

  • Polymorph investigations
  • Control and measurement of impurities
  • Kinetics of nucleation and growth
  • Crystal size distribution measurement and modification
  • Habit modification
  • Filtration studies
  • Drying investigations
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Product Environmental Testing
Price on request

Environmental Conditioning, Cycling and Simulation Testing

We employ high-performance Cincinnati Sub-Zero environmental chambers to provide conditioning, accelerated aging and real-time storage programs to pharmaceutical/biotechnology, medical device and consumer product manufacturers.

Our experts perform accelerated aging... Show more »

Environmental Conditioning, Cycling and Simulation Testing

We employ high-performance Cincinnati Sub-Zero environmental chambers to provide conditioning, accelerated aging and real-time storage programs to pharmaceutical/biotechnology, medical device and consumer product manufacturers.

Our experts perform accelerated aging on materials, products and packaging systems including packaged medical devices to provide a theoretical equivalent to real-time shelf life. Accelerated-aging conditioning, based on the Q10 theory of ASTM F1980, allows you to evaluate your package system performance.

Our series of qualified test chambers helps you evaluate and define shelf life claims in a fraction of the time. We also offer real-time aging programs and storage at typical conditions in one integrated laboratory.

We continually upgrade and expand our state-of-the-art equipment. We offer a variety of core conditions for your testing needs:

  • -30°C to +60°C walk-in environmental chamber for larger projects
  • +23°C ± 1°C /50% RH ± 2% walk-in environmental chamber for real-time/controlled environment, ASTM and TAPPI
  • Reach-in and bench-top chambers with capabilities from -70°C to +190°C for developmental studies
  • +5°C ± 3°C ICH refrigerated long-term storage
  • +25°C ± 2°C/60% RH ± 5% ICH long-term/accelerated (refrigerated)
  • +30°C ± 2°C/65% RH ± 5% ICH intermediate (Zones I, II, III and IVa)
  • +30°C ± 2°C/75% RH ± 5% ICH long-term (Zone IVb)
  • +40°C ± 2°C/75% RH ± 5% ICH accelerated (Zones I–IV)
  • -20°C ± 5°C ICH long-term (frozen) -70°C through -90°C cryogenic storage

Our precision CSZ temperature/humidity chambers are fully programmable for profile cycle testing, including:

  • Thermal performance of packaging
  • Product quality and reliability
  • Product life expectancy
  • Drug stability protocols
  • Forced degradation studies

Thermal cycle testing is important for product and package development to ensure that adverse effects from extremes in climatic conditions do not harm the efficacy of drug products, that packaging protects products from excursions in temperature and humidity and that the packaging itself does not deteriorate under extremes in climatic conditions.

We conduct package and distribution testing in accordance with the following industry guidances:

Pharmaceutical/Drug Stability/Cold Chain Package

  • PDA TR #53 Stability Testing to Support Distribution of New Drug Products
  • PDA TR #39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment
  • ICH Q1C Stability Testing for New Dosage Forms
  • ISTA Standard 20/7E Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment
  • ISTA 7D Temperature Test for Transport Packaging

Medical Device Package

  • ASTM D 4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
  • ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ASTM F 2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
  • ISO 11607 Packaging for Terminally Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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Polymorphism Screening
Price on request

SOLID FORM SCREENING AND SELECTION

A comprehensive study of polymorphism is required prior to NDA filing and is also necessary for intellectual property reasons. The pharmaceutical industry strives for improved efficiency in screening and selection of new chemical entities and in other areas where automation of process and data... Show more »

SOLID FORM SCREENING AND SELECTION

A comprehensive study of polymorphism is required prior to NDA filing and is also necessary for intellectual property reasons. The pharmaceutical industry strives for improved efficiency in screening and selection of new chemical entities and in other areas where automation of process and data collection are appropriate.

To that end, an effective polymorph screening strategy relies on many experimental techniques in addition to solvent-mediated experimentation. We conduct our screens with the widest available experimental approaches, using common as well as proprietary search mechanisms. Proven to find more forms than standard screening strategies, our typical polymorph screen will employ:

  • Solvent-mediated screening
  • Fast evaporation
  • Slow evaporation
  • Mechanical techniques
  • Grinding
  • Thermal techniques
  • Computational pattern matching and TRIADS indexing analysis (U.S. Patents 7372941 and 8576985)

We believe X-ray powder diffraction is the best first method to discriminate solid forms and provide critical data for property determination and structural exploration. Additionally, by applying our computational models, we collect high-quality data to develop a deep structural understanding of the solid forms present and predict properties including relative thermodynamic stability, habit, density and electron density.

Based on the time and materials available, we offer a variety of screen types, which we tailor to your specific needs.

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Salt Screening
Price on request

Salt Screening and Selection

Our salt screen involves a search for solid salts of ionizable drug products using sources of pharmaceutically acceptable counterions as well as knowledge of their properties, frequency of use in drug products and manufacturability. The desire to use a salt screen is usually due to poor drug... Show more »

Salt Screening and Selection

Our salt screen involves a search for solid salts of ionizable drug products using sources of pharmaceutically acceptable counterions as well as knowledge of their properties, frequency of use in drug products and manufacturability. The desire to use a salt screen is usually due to poor drug substance properties such as lack of crystallinity, water solubility or stability. We design the salt screen based on the improvement desired and properties of the API, often using a tiered testing procedure to quickly identify the salts with optimum properties.

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Solubility Studies
Price on request

Solid Dispersion Screen

Poor aqueous solubility frequently occurs during the development of new drug products. To address solubility issues, we employ numerous techniques to search for and stabilize amorphous forms of drug substance. Amorphous materials are generally much more soluble than their crystalline counterparts,... Show more »

Solid Dispersion Screen

Poor aqueous solubility frequently occurs during the development of new drug products. To address solubility issues, we employ numerous techniques to search for and stabilize amorphous forms of drug substance. Amorphous materials are generally much more soluble than their crystalline counterparts, and we can often formulate them to be physically and chemically stable throughout the shelf life of the drug product.

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Solid Dosage Formulation
Price on request

Selection of Optimum Solid Form of Drug Substance

We have extensive experience in solid sample generation from microgram to multigram scale. Our expertise ranges from synthesis to salt formation to specialized techniques for making metastable polymorphic forms. We generate and characterize crystalline polymorphs, hydrates,... Show more »

Selection of Optimum Solid Form of Drug Substance

We have extensive experience in solid sample generation from microgram to multigram scale. Our expertise ranges from synthesis to salt formation to specialized techniques for making metastable polymorphic forms. We generate and characterize crystalline polymorphs, hydrates, solvates, desolvated solvates, salts and amorphous forms.

The properties of a solid that are important to its efficacy as a drug or excipient are highly dependent on the form of the solid. To help you secure FDA approval of an NDA, we use a tiered approach to select the optimal form of your specific drug for your specific application. Our approach includes salt selection, polymorph screening and cocrystal screening, and comparative property determinations. We can work with you to plan a research proposal aimed at selection of the best form of your compound for development and manufacture.

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Drug Formulation Development
Price on request

Selection of Optimum Solid Form of Drug Substance

We have extensive experience in solid sample generation from microgram to multigram scale. Our expertise ranges from synthesis to salt formation to specialized techniques for making metastable polymorphic forms. We generate and characterize crystalline polymorphs, hydrates,... Show more »

Selection of Optimum Solid Form of Drug Substance

We have extensive experience in solid sample generation from microgram to multigram scale. Our expertise ranges from synthesis to salt formation to specialized techniques for making metastable polymorphic forms. We generate and characterize crystalline polymorphs, hydrates, solvates, desolvated solvates, salts and amorphous forms.

The properties of a solid that are important to its efficacy as a drug or excipient are highly dependent on the form of the solid. To help you secure FDA approval of an NDA, we use a tiered approach to select the optimal form of your specific drug for your specific application. Our approach includes salt selection, polymorph screening and cocrystal screening, and comparative property determinations. We can work with you to plan a research proposal aimed at selection of the best form of your compound for development and manufacture.

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Thermodynamic Property Analysis
Price on request

We can help you easily visualize thermodynamic properties of polymorphic forms by using energy temperature diagrams. These diagrams plot relative enthalpies and free energies versus temperature. They may be constructed using thermal, solubility, infrared and/or interconversion data.

We can help you easily visualize thermodynamic properties of polymorphic forms by using energy temperature diagrams. These diagrams plot relative enthalpies and free energies versus temperature. They may be constructed using thermal, solubility, infrared and/or interconversion data.

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Chiral Resolution
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Chiral Material Analysis and Resolution

Like polymorphs, solid forms attained from racemic mixtures of a given chiral compound can be crystallographically distinct. A racemic mixture in the solid form may exist as a racemic compound (a racemate) whereby pairs of enantiomers are present within a single crystal structure, or a... Show more »

Chiral Material Analysis and Resolution

Like polymorphs, solid forms attained from racemic mixtures of a given chiral compound can be crystallographically distinct. A racemic mixture in the solid form may exist as a racemic compound (a racemate) whereby pairs of enantiomers are present within a single crystal structure, or a conglomerate, constituted from a physical mixture of two crystal phases in equivalent amounts, each containing single enantiomers. Our solids analysis capabilities enable determination of these relationships.

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Dynamic Vapor Sorption
Price on request
Request a quote for more information about this service.
Loss on Drying Testing
Price on request

Water plays an important role in solid state pharmaceutical systems due to its impact on the chemical and physical stability of a drug substance and drug product, as well as on key physical properties that influence storage conditions.

We use various techniques to provide information on water content, hygroscopicity and hydrate formation, including Loss on Drying (LOD).

Water plays an important role in solid state pharmaceutical systems due to its impact on the chemical and physical stability of a drug substance and drug product, as well as on key physical properties that influence storage conditions.

We use various techniques to provide information on water content, hygroscopicity and hydrate formation, including Loss on Drying (LOD).

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Calorimetry
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Melting Point Determination
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Differential Scanning Calorimetry (DSC)
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Optical Microscopy
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We routinely use results from microscopy studies to complement analytical data from other techniques to address your solid state characterization issues. Microscopy with appropriate sample handling is also a powerful tool for trace analysis.

We offer complete microscopy capabilities:

We routinely use results from microscopy studies to complement analytical data from other techniques to address your solid state characterization issues. Microscopy with appropriate sample handling is also a powerful tool for trace analysis.

We offer complete microscopy capabilities:

  • Light microscopy including polarizing, bright field and dark field
  • Fluorescence Infrared (IR)
  • Raman Scanning electron microscopy (SEM)
  • High vacuum
  • Low vacuum
  • Energy dispersive X-ray analysis (EDX)
  • Hot stage (light microscopy, IR, Raman)
  • Cold stage (light microscopy, IR, Raman)
  • Stereomicroscopy
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Cleaning Validation Services
Price on request

Our technical experts will validate your cleaning process to ensure the removal of cross-contamination, contamination and residuals. The FDA requires that cleaning validations are performed when changes occur in the procedure, equipment, formulations and cleaning procedures because they have a direct impact on the finished... Show more »

Our technical experts will validate your cleaning process to ensure the removal of cross-contamination, contamination and residuals. The FDA requires that cleaning validations are performed when changes occur in the procedure, equipment, formulations and cleaning procedures because they have a direct impact on the finished product. Sampling techniques can include rinsing, swabbing and other product-specific practices.

We assist you with the development and validation of analytical methods, addressing critical attributes such as precision, linearity, recovery, LOD and LOQ. In addition to developing analytical methods, we can also apply nonspecific methods such as total organic carbon (TOC) for detection of all carbon-containing compounds that are soluble in water. The sensitivity of TOC obtains results in the ppb range. We use both methods in routine analysis of cleaning validation samples.

Our cleaning validation methods include:

  • Total Organic Carbon
  • ASTM F2847 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
  • ASTM-F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
  • ASTM F1877 Standard Practice for Characterization of Particles
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Protein Crystallization Screening and Optimization
Price on request

PROTEIN AND PEPTIDE CRYSTALLIZATION

Most biological pharmaceuticals such as proteins, peptides and oligonucleotides are supplied as aqueous solution or lyophilized solids. To date, insulin is the only biologic available in a crystalline formulation.

A crystalline formulation has some advantages over its amorphous... Show more »

PROTEIN AND PEPTIDE CRYSTALLIZATION

Most biological pharmaceuticals such as proteins, peptides and oligonucleotides are supplied as aqueous solution or lyophilized solids. To date, insulin is the only biologic available in a crystalline formulation.

A crystalline formulation has some advantages over its amorphous counterpart, including high concentration and high purity: In the crystalline form, the protein molecules exist in the most concentrated form and retain an active conformation. Second, a crystalline formulation offers the possibility of controlled release because the dissolution rate in aqueous solution is low relative to the amorphous material. Third, crystalline material may offer greater physical and chemical stability than liquid solutions or the amorphous state due to higher purity, its more compact molecular arrangement and restricted molecular motion.

Our expert scientists offer crystallization screening using a variety of crystallization techniques. We conduct initial screening on a small scale using various vapor diffusion techniques (sitting drop, hanging drop, sandwich drop and capillary) and batch crystallization techniques (slow evaporation, fast evaporation and anti-solvent precipitation). We further optimize and scale up the conditions in which crystallization occurs. The batch crystallization process can also be applied to large-scale purification.

We also use these crystallization techniques for single crystal growth of proteins and peptides for 3-D structure determination.

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Analytical Method Development
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

We specialize in biochemical method development, transfer and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR and assays. Our scientists develop and validate all methods according to ICH guidelines for accuracy, precision... Show more »

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

We specialize in biochemical method development, transfer and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR and assays. Our scientists develop and validate all methods according to ICH guidelines for accuracy, precision (repeatability and intermediate precision), specificity, limit of detection, limit of quantitation, linearity, range and robustness.

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Protein Formulation
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PROTEIN FORMULATION DEVELOPMENT

Per the specifications outlined in ICH Q6B, we offer analytical services in support of protein drug development to determine physical and chemical instabilities at different stages. The molecular structure of protein is delicate and highly sensitive to environmental changes and stresses. Ensuring... Show more »

PROTEIN FORMULATION DEVELOPMENT

Per the specifications outlined in ICH Q6B, we offer analytical services in support of protein drug development to determine physical and chemical instabilities at different stages. The molecular structure of protein is delicate and highly sensitive to environmental changes and stresses. Ensuring native-like higher order structure in a biologic is essential because the overall conformation defines the drug’s stability, biological activity, efficacy and safety.

We apply numerous techniques (e.g., freeze-drying and spray drying) for solid state protein formulation development and to tailor test to your specific needs.

Preformulation Screen

We evaluate the physical stability of protein in various formulation excipients such as ionic strength, buffers, pH, surfactants, sugars, salts, antioxidants and amino acids on the physicochemical properties of the protein.

  • Gel permeation chromatography and size exclusion chromatography, coupled with a static-light-scattering detector, to detect and quantify protein aggregation
  • Nano-DSC to monitor conformational stability of biologics in their formulations; detecting structural alterations (unfolding/aggregation) in a biologic in the form of a Tm (denaturation temperature) shift or a change in the shape of the endothermic peak (∆H and ∆Hv for domain and subunit organization)
  • Dynamic light scattering (DLS) or quasi-elastic light scattering to evaluate the aggregation state; nondestructive DLS determines size distribution of particles in the diameter range of 1 nm to 2 µm

Lyophilization Process Development and Optimization

We offer small-scale lyophilization services to screen common excipients for protein stability.

  • Protein formulation in compatible excipients based on the physicochemical properties of the protein Temperature-modulated differential scanning calorimetry to determine the glass transition temperature of the formulation in the frozen state (Tg’) and freeze-drying microscopy to determine the collapse temperature
  • Optimal shelf temperatures and chamber pressures for primary and secondary drying
  • Characterization of the finished lyophilized product using X-ray powder diffraction and polarized light microscopy to assess crystallinity; thermogravimetry and DSC for thermal properties; scanning electron microscopy for particle morphology; Karl Fischer titration for water content; dynamic vapor sorption/desorption for hygroscopicity testing and solid state NMR; FTIR and Raman spectroscopy for chemical and physical fingerprinting
  • Evaluation of physical stability (unfolding/aggregation) of protein upon lyophilization by SEC, nano-DSC, DLS, CD and HPLC

Real-Time and Accelerated Stability Studies

Storage stability of proteins correlates with the degree of retention of native structure of proteins and the level of hydration during drying. Environmental conditions such as temperature, pH, ionic strength, oxygen and protease content can cause denaturation, aggregation, degradation and chemical modification (oxidation and deamidation). We offer advanced analytical methodologies for stability evaluation that ensure structural integrity and physicochemical identity.

  • Physical stability assessment: Aggregation state evaluation by SEC and DLS, conformational change by nano-DSC and solid state characterization by various analytical techniques including XRPD, TG, DSC, SEM, SSNMR, FTIR and Raman - - - Chemical stability assessment: Ultra-high resolution Q-TOF mass spectrometer and solids/liquids NMR spectrometer in conjunction with techniques such as peptide mapping, MALDI-TOF MS, amino acid analysis and Edman N-terminal sequencing for accurate mass and primary sequence of proteins and peptides
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Structure Determination
Price on request

STRUCTURE ELUCIDATION

We provide a complete suite of expert structure elucidation techniques for proteins, peptides, oligonucleotides, PEGylated proteins and small molecule drugs, antibody-drug conjugates (ADCs) and other polymers:

Mass spectrometry

  • Ultra-high resolution Q-TOF mass spectrometer for accurate... Show more »

STRUCTURE ELUCIDATION

We provide a complete suite of expert structure elucidation techniques for proteins, peptides, oligonucleotides, PEGylated proteins and small molecule drugs, antibody-drug conjugates (ADCs) and other polymers:

Mass spectrometry

  • Ultra-high resolution Q-TOF mass spectrometer for accurate identification of proteins, peptides, oligonucleotides, PEGylated proteins and small molecule drugs, ADCs and other polymers in extremely small quantities
  • De novo peptide sequencing and identification of modified sites using MS/MS High-resolution MS for accurate determination of drug-to-antibody ratio and drug load distribution of ADCs

NMR spectroscopy

  • Determination of the 3-D structures of proteins, peptides and oligonucleotides
  • NMR spectrometer equipped for liquid and solid state analysis, providing comprehensive 1-D and 2-D spectra data for identification and structure determination

Single crystal structure determination of peptides

  • Services for single crystal screening and three-dimensional structure determination by X-ray diffraction

INITIAL DRUG SUBSTANCE CHARACTERIZATION

Structure Elucidation

  • Nuclear magnetic resonance (NMR)
  • Solution NMR spectroscopy IR spectroscopy
  • Single crystal structure determination
  • Mass spectrometry

Physical Characterization

  • X-ray powder diffraction
  • Optical microscopy
  • Differential scanning calorimetry
  • Thermogravimetry
  • Melting point determination
  • Moisture sorption/desorption isotherms
  • Infrared spectroscopy
  • Raman spectroscopy
  • Solid state NMR spectroscopy
  • Ultraviolet spectrum
  • Particle size distribution
  • Surface area
  • Scanning electron microscopy
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Protein Aggregation Analysis
Price on request

AGGREGATION STATE CHARACTERIZATION

Protein aggregation is a critical quality attribute that may increase the risk of immune response. Protein aggregates can form during production, storage or shipment. Many environmental conditions (e.g., mechanical stress, pH, ionic strength, temperature, light or oxidation) lead to protein... Show more »

AGGREGATION STATE CHARACTERIZATION

Protein aggregation is a critical quality attribute that may increase the risk of immune response. Protein aggregates can form during production, storage or shipment. Many environmental conditions (e.g., mechanical stress, pH, ionic strength, temperature, light or oxidation) lead to protein unfolding, misfolding and aggregation by physical interaction or covalent bonding.

Our scientists have extensive experience in characterization of aggregates in solution, including proteins/peptides, oligonucleotides and other polymers. We employ a complete suite of advanced analytical techniques:

  • SEC-MALS and GPC (gel permeation chromatography) for molecular weight estimation
  • DLS for particle size (hydrodynamic radius)
  • SEM for particle morphology
  • Native/SDS-PAGE and IEF for molecular weight and isoelectric point
  • IR microscopy and NMR spectroscopy for probing conformational changes
  • Near- and far-UV circular dichroism spectrophotometry for high order structural analyses
  • Free sulfhydryl group determination
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Water Quality Testing
Price on request

We determine the microbiological quality of environmental water and water produced for pharmaceutical purposes to ensure the safety of finished products, processes and the consumer.

To assess the quality of water used for manufacturing and cleaning purposes, we perform water testing during purified water system installation as... Show more »

We determine the microbiological quality of environmental water and water produced for pharmaceutical purposes to ensure the safety of finished products, processes and the consumer.

To assess the quality of water used for manufacturing and cleaning purposes, we perform water testing during purified water system installation as well as validation, performance verification and routine monitoring to evaluate whether water systems are within acceptable levels of control. The feed water should also be monitored and controlled. Enumeration of microorganisms is a critical component in water testing. The assessment of the microbiological quality of water used in manufacturing is a key indicator of system control.

Bioburden testing includes the quantitation of microbes such as aerobic plate count, yeast/mold count, heterotrophic plate count, total coliforms, coli, Enterococci, Listeria and Pseudomonas aeruginosa. For water for injection, bacterial endotoxin testing is also required.

Our range of water testing services includes:

  • Bioburden Total organic carbon (TOC) Conductivity
  • Heavy metals testing
  • Bacterial endotoxin testing
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Impurity Analysis
Price on request

PRODUCT-RELATED IMPURITY CHARACTERIZATION

According to ICH Q6B guidelines, impurities in biological products can be classified as process-related or product-related. Process-related impurities include those that are derived from the manufacturing process (e.g., cell substrates, cell culture media components or downstream... Show more »

PRODUCT-RELATED IMPURITY CHARACTERIZATION

According to ICH Q6B guidelines, impurities in biological products can be classified as process-related or product-related. Process-related impurities include those that are derived from the manufacturing process (e.g., cell substrates, cell culture media components or downstream processing). Product-related impurities in the drug substance are molecular variants with properties different from those of the desired product formed during manufacture or storage.

To characterize these impurities, we offer a complete suite of analytical techniques for the isolation and characterization of process- and product-related impurities:

  • Isolation and purification by LC: Reversed phase, ion exchange, size exclusion
  • Identification: Mass spectrometry (ESI-Triple Quad, MALDI-TOF, Q-TOF), NMR (1D and 2D), FTIR, Raman and UV-Vis spectroscopy, N-terminal Edman sequencing, LC-MS/MS de novo sequencing, peptide mapping, disulfide bond mapping, amino acid analysis

Extractables and Leachables

Impurities may occur through chemical reaction and degradation during API and drug product production and storage, as the result of remaining residual solvents or due to the introduction of contaminants. Furthermore, the contacting materials introduced during production and storage may introduce extractables and leachables (E&L).

Determine the path to mitigate downstream product risk. Our experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk. We possess detailed ICH and USP regulatory knowledge regarding the control of impurities and their associated levels in new drug products and new drug substances.

With our expertise in chemical synthesis, drug product formulation development, bioprocessing and small- and large-scale API manufacturing, along with analytical expertise in stability programs, release testing, structure elucidation and E&L determination, we provide significant resources and probability of success to address your impurity needs.

Our capabilities include:

  • Identification of impurities
  • Method development and validation to determine type and level of impurities
  • Use of analytical instrumentation (mass spectrometry and NMR) for structure elucidation
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Environmental Monitoring
Price on request

We provide environmental monitoring services to evaluate your cleaning and disinfection programs, assessing the microbial cleanliness of your manufacturing environment per USP <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. This information will enable you to control microorganism levels... Show more »

We provide environmental monitoring services to evaluate your cleaning and disinfection programs, assessing the microbial cleanliness of your manufacturing environment per USP <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. This information will enable you to control microorganism levels in the manufacturing environment and minimize the bioburden on the item that is manufactured.

With our help, you can confidently implement environmental monitoring programs in cleanrooms, manufacturing plants, packaging facilities, testing laboratories and other areas where microbial and particulate control are critical to the quality of operations and production, such as medical device manufacturing and packaging, sterile and aseptic production and fill environments, and sterile and aseptic product primary and secondary packaging areas.

We take air and surface samples during production to obtain a microbiological profile of the manufacturing environment and record additional observations of work practices during the survey. Our experts evaluate the data to determine any actions you can take to reduce or stabilize the bioburden of the medical product or production area.

Programs include viable and nonviable air monitoring, cleaning effectiveness, equipment monitoring, surface monitoring, disinfectant efficacy, gowning and personnel monitoring, compressed air testing, compressed gas testing and water system validation monitoring.

New facilities, new programs, construction areas, adjacent areas, post-construction areas and change control typically warrant a risk assessment and program design that may include evaluation of:

  • Baseline bioburden and particulates (often including seasonal trending)
  • Identification of organisms across the baseline sample
  • Process, procedure and practice

Once we conduct a comprehensive evaluation, we recommend a program be implemented with a defined frequency and specifications established either by regulatory requirements or trending data.

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Ligand Binding Assays
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product.

Our services characterize:
- Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition
- Purity and impurity: LC (reversed phase, ion exchange, and size exclusion) electrophoresis (native/SDS-PAGE, isoelectric focusing)
- Potency: Ligand binding assays and functional assays

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Disinfectant Efficacy Testing
Price on request

Per USP <1072>, we provide expert services to test disinfectant efficacy. Disinfection and cleaning of critical areas is a key component to successful control of these environments. In addition to validating the cleaning process, the disinfectants and antiseptics implemented should be qualified. At the minimum, this should... Show more »

Per USP <1072>, we provide expert services to test disinfectant efficacy. Disinfection and cleaning of critical areas is a key component to successful control of these environments. In addition to validating the cleaning process, the disinfectants and antiseptics implemented should be qualified. At the minimum, this should include a review of vendor certificates and data. Actual testing is also often required, such as use-dilution tests (e.g., AOAC 955.14, 955.15, 964.02), which verify the dilution of disinfectants against specified microbial strains. Additional tests needed may also include Sporicidal Activity of Disinfectants (AOAC 966.04), germicidal spray products tests, confirmatory tuberculocidal activity tests and fungicidal activity.

For your sanitizer or disinfectant efficacy study, we can also perform simulation studies, hard surface tests and tests under nominal conditions/procedures. Disinfectant validation may also include in vitro tests: a time kill study or suspension testing, coupon or carrier testing, environmental monitoring and in situ testing.

In designing a disinfectant efficacy validation or verification solution, our experts consider the following factors:

  • Surfaces present in the critical area, including different conditions or types of the same material
  • Each disinfectant and dilution to be challenged by a panel of representative organisms
  • Testing for standard USP organisms: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis (spore), Candida albicans and Aspergillus brasiliensis
  • Panel to include environmental isolates collected from environmental monitoring of the facility or critical area -
  • Expiration verification through the use of aged disinfectant preparations
  • Neutralization of the disinfectant, e.g., suitability testing
  • Recovery method evaluation or control
  • Cleaning process overview and validation: Facility materials and environment, disinfectant preparation, cleaning procedure and contact time, facility surfaces, facility-specific bacteria and fungi
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Electrophoresis
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product.

Our services characterize:

  • Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition
  • Purity and impurity: LC (reversed phase, ion exchange, and size exclusion) electrophoresis (native/SDS-PAGE, isoelectric focusing)
  • Potency: Ligand binding assays and functional assays
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UV-VIS Spectroscopy
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition

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Raman spectroscopy
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition

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Cytotoxicity Assays
Price on request

We offer market-leading expertise in cytotoxicity assays. Our scientists use cell culture assays to assess the biocompatibility of a material or extract through an in vitro reaction of mammalian cells following exposure. These may be plastics or elastomers used as containers or to seal containers that will hold drugs or other... Show more »

We offer market-leading expertise in cytotoxicity assays. Our scientists use cell culture assays to assess the biocompatibility of a material or extract through an in vitro reaction of mammalian cells following exposure. These may be plastics or elastomers used as containers or to seal containers that will hold drugs or other solutions for parenteral administration (e.g., intravenous (IV) bags, IV tubing), plastics that will directly contact the patient (e.g., knee brace material, dentures, contact lenses, catheters) or materials that may be implanted (e.g., medical devices: joint replacements or cochlear implants).

Biological reactivity techniques are useful in evaluating the potential of materials and chemicals to have toxic properties. They provide a way to screen materials prior to, or in lieu of, in vivo tests.

We perform three methods of cytotoxicity testing as outlined by the USP:

  • Elution Assay: Uses different extracting media and extraction conditions to test devices according to actual use conditions or to exaggerate those conditions
  • Direct Contact Procedure: Recommended for low-density materials, such as contact lens polymers
  • Agar Diffusion Assay: Appropriate for high-density materials, such as elastomeric closures

Our experts can also perform ISO or custom methods for cytotoxicity tests, as well as quantitative assays that employ techniques to measure cell viability after exposure.

Cytotoxicity Testing: ISO 10993-5

Medical devices that have direct or indirect contact with body tissue raise quality issues about the biocompatibility of the product and must be tested before being brought to market (CE-certification). Catheters, inhalators, implants, wound dressings and other medical device products must meet the highest quality standards to ensure proper product functioning.

To measure medical device biocompatibility, we provide in vitro cytotoxicity testing. In this type of test, mammalian cells are cultivated with direct contact with the medical device materials, or a material extract of the medical device is pipetted onto precultivated mice cells to test cell vitality.

Our cytotoxicity testing services include:

  • Evaluating the impact of sterilization, packaging and material surface treatment processes on the biocompatibility of products
  • Batch testing during medical device production
  • CE certification of a medical device
  • Testing suppliers’ product quality
  • Comparative testing of biocompatibility of a competitor product

Ethylene Oxide Residual Testing: ISO 10993-7

Ethylene oxide (ETO) is a commonly used sterilant in the manufacture of medical devices because it does not adversely affect the materials used to manufacture medical devices. ISO 10993-7 specifies allowable limits for residual EO and its degradants, ethylene chlorohydrin (ECH) and ethylene glycol (EG).

We provide analytical ETO residual testing of terminally sterilized medical devices using currently accepted gas chromatography (GC) methods:

  • GC water extracts for ETO
  • GC water extracts for EG and ECH
  • GC with solid-phase micro extraction
  • GC using headspace sampling for ETO

Our experts also perform ETO residual testing in compliance with the guidelines provided by ANSI/AAMI/ISO 10993-7.

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NMR
Nuclear magnetic resonance spectroscopy
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition

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MALDI Mass Spectrometry Methods
Price on request

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high... Show more »

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition

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Mass Spectrometry
Price on request

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the... Show more »

ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.

We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:

Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition

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Regulatory Affairs Services
Price on request

REGULATORY ASPECTS OF BIOLOGICAL PHARMACEUTICALS

The growing number of biologics advancing to market brings an increased demand for thorough characterization. To meet these needs, our scientists provide a complete suite of characterization capabilities. Unlike traditional small molecule drugs, biological products are inherently... Show more »

REGULATORY ASPECTS OF BIOLOGICAL PHARMACEUTICALS

The growing number of biologics advancing to market brings an increased demand for thorough characterization. To meet these needs, our scientists provide a complete suite of characterization capabilities. Unlike traditional small molecule drugs, biological products are inherently heterogeneous, so differences in molecular structure or the presence of impurities can dramatically change efficacy, immunogenicity or toxicity.

We also help you navigate critical regulatory guidances. The ICH defines guidelines regarding quality, specifications, stability, comparability and method validation in development activities concerning biological products. The guidance calls for inclusion of analytical methods for control of API as well as adventitious agents. It also specifies that the physicochemical and biological properties of biomolecules be defined, especially as they relate to manufacturing. Acceptance criteria are also recommended.

The guidance on specifications indicates that identity tests should be highly specific for the drug substance or drug product and should be based on unique aspects of its molecular structure and/or other specific properties. More than one test (physicochemical, biological and/or immunochemical) may be necessary to establish identity. Physicochemical characterization generally includes determination of the composition, physical properties and primary structure of the desired biological product. In some cases, information regarding a higher order structure may be obtained by appropriate physicochemical methodologies. The purity and impurities of biological products are usually estimated by a combination of methods (e.g., HPLC, UPLC and electrophoresis).

Stability tests are necessary, especially for protein and peptide drugs due to their structural complexity and instability. The most common chemical degradation mechanisms for peptides and proteins are deamidation and oxidation. The guidance on stability of peptides and proteins recommends tests of both chemical stability and biological activity.

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Gas Testing
Price on request

We invest in the specialized expertise and technology required to offer comprehensive gas testing services for our pharmaceutical and biotechnology clients. Our quality assurance team works with you to develop gas testing protocols and validation reports to ensure your company meets FDA requirements for medical/process gas... Show more »

We invest in the specialized expertise and technology required to offer comprehensive gas testing services for our pharmaceutical and biotechnology clients. Our quality assurance team works with you to develop gas testing protocols and validation reports to ensure your company meets FDA requirements for medical/process gas usage.

To reduce the likelihood of sampling errors and test failures, we offer on-site sampling. If you do not require on-site sampling, we will assist you with sample cylinder rental and shipping, as well as provide complete instructions for sample processing. We also offer an extensive inventory of stainless steel sample cylinders that undergo a routine, extensive cleaning process.

Our gas testing capabilities include:

  • USP/EP Nitrogen
  • USP/EP Oxygen
  • USP/EP Carbon Dioxide
  • USP/EP Helium
  • USP/EP Medical Air
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Antimicrobial Effectiveness Testing
Price on request

We perform antimicrobial effectiveness testing (AET) or preservative effectiveness testing to help evaluate your product’s ability to withstand microbial contamination during use. Our experts provide this testing for injections packaged in multiple-dose containers, as well as for products containing antimicrobial preservatives. We... Show more »

We perform antimicrobial effectiveness testing (AET) or preservative effectiveness testing to help evaluate your product’s ability to withstand microbial contamination during use. Our experts provide this testing for injections packaged in multiple-dose containers, as well as for products containing antimicrobial preservatives. We also test products such as aqueous-based, multiple-dose topical and oral dosage forms, and pharmaceutical dosage forms including otic, ophthalmic, irrigation, nasal and dialysis fluids.

This type of test is performed according to USP <51> Antimicrobial Effectiveness Testing, EP 5.1.3 Efficacy of Antimicrobial Preservation and CTFA Preservative Challenge Testing. Testing for the following microorganisms is required per USP <51>: Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis and Pseudomonas aeruginosa.

We perform antimicrobial effectiveness testing for method suitability and for routine testing. Our capabilities for bioburden testing include:

  • Membrane Filtration Method: A quantitative technique that isolates colonies of bacteria and fungi from a fluid sample using a membrane filter and vacuum

  • Standard Plate Count/Pour Plate Method: Isolates bacteria and fungi by plating a sample preparation to a petri dish and adding nutrient agar that allows growth of any microorganisms present

  • Spread Plate Method: Isolates bacteria and fungi by plating a sample preparation to a nutrient agar plate GMP-compliant stability chambers for storing your products, which we monitor for temperature and humidity

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Endotoxin Testing
Price on request

To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection and APIs, our experts offer testing for the detection and control of endotoxins. USP <85> Bacterial Endotoxins Test and USP <161> Transfusion and Infusion Assemblies and Similar Medical... Show more »

To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection and APIs, our experts offer testing for the detection and control of endotoxins. USP <85> Bacterial Endotoxins Test and USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices specify endotoxin testing requirements, including for medical devices with direct blood or cerebrospinal fluid contact.

Bacterial endotoxins are pyrogens produced in bacteria, which cause fever in humans and other animals. Limulus amebocyte lysate (LAL) is the most common reagent used to detect bacterial endotoxin contamination. The gold standard per USP for testing is the gel clot method.

Testing should be performed on every production lot prior to release. Endotoxin limits are typically established based on formulation, dosage per hour, route of administration and average patient weight, but may also incorporate trending data as well as monograph specifications.

Endotoxin method validation is performed on every product and/or formulation. Validation, or inhibition and enhancement (I/E) testing, ensures that the sample does not interfere with the method, which could lead to false positive or negative data. Validation also ensures proper sensitivity, diluent selection and dilution factor.

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Crystal Structure Determination
Price on request

Crystal Structure Determination From X-Ray Powder Diffraction

On occasion, suitable single crystals cannot be grown for a given molecule or particular solid form thereof. If a good quality powder sample is available, we can often determine the crystal structure using computational methods.

We have a long track record of... Show more »

Crystal Structure Determination From X-Ray Powder Diffraction

On occasion, suitable single crystals cannot be grown for a given molecule or particular solid form thereof. If a good quality powder sample is available, we can often determine the crystal structure using computational methods.

We have a long track record of solving structures from powder data. Although we have experience with synchrotron data, in most cases good results can be obtained using our in-house, high-resolution XRPD data.

We perform a structure solution using a computational method called simulated annealing, in which the molecular structure is used as the input model and the conformation, orientation and position of the molecule is varied until a plausible solution is found. Larger, flexible molecules and multicomponent crystals require more computational time. We have a parallel implementation for structure solution. The more complicated ketoconazole cocrystals showcased in the application note were solved in overnight calculations.

The major caveat, in comparison to structure determination from single crystals, is that the absolute configuration cannot be determined from powder data due to the overlap of the Friedel pair intensities needed for that analysis. We recommend performing additional experimental testing to confirm the molecular structure and the composition in case of solvated crystals using vibrational spectroscopy.

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Microbial Limit Testing
Price on request

We perform bioburden/microbial enumeration testing (MET) on various pharmaceutical articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products. MET includes assessment of the physical characteristics and inherent... Show more »

We perform bioburden/microbial enumeration testing (MET) on various pharmaceutical articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products. MET includes assessment of the physical characteristics and inherent antimicrobial properties of the product in question.

Bioburden testing ensures that pre-sterilization microbial load is within the tolerance of the sterilization cycle, residuals after sterilization are at acceptable levels and products are properly sterilized throughout the program. Bioburden testing is also used during the release of a product to market in order to demonstrate that the manufacturing process remains in control. This testing includes enumeration by total aerobic microbial count and total yeast and mold count.

Regulatory bodies require monitoring of the bioburden load in products used for humans and animals to ensure product safety according to procedures outlined USP <61> and <62> guidances:

  • USP <61> An enumeration test, sometimes referred to as bioburden, that quantifies microorganisms in nonsterile products or raw materials
  • USP <62> Testing for the presence or absence of specific organisms in a product, which can include Escherichia coli, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species, Clostridia species and bile tolerant gram negative bacteria

USP <61> and USP <62> testing provides harmonization to the European Pharmacopeia methods for testing nonsterile pharmaceuticals.

To conduct bioburden testing, we apply the following techniques:

  • Membrane filtration method
  • Standard plate count
  • Pour plate method
  • Most probable number
  • Direct enrichment Membrane filtration enrichment
  • Microbiological Population Verification
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X-Ray Powder Diffraction
Price on request

X-ray powder diffraction (XRPD) is one of the most powerful methods for the study of crystalline and partially crystalline solid state materials. Each crystalline form has a unique powder diffraction fingerprint that can be used to identify the presence of that form within a sample. We have extensive experience in the... Show more »

X-ray powder diffraction (XRPD) is one of the most powerful methods for the study of crystalline and partially crystalline solid state materials. Each crystalline form has a unique powder diffraction fingerprint that can be used to identify the presence of that form within a sample. We have extensive experience in the interpretation of powder diffraction patterns and have developed unique methodologies for fully automated recognition of crystalline forms.

As a crystalline form becomes disordered, it may pass through microcrystalline and nanocrystalline forms before reaching a final amorphous or random form. Like the crystalline form, each of these disordered forms has a unique diffraction fingerprint that we can extract with our proprietary pattern recognition software, enabling each form’s identification within a sample. The relative amounts of each of these unique diffraction patterns can be used to quantify sample composition. We have a range of controlled humidity and temperature chambers where the thermodynamics of these various crystalline and disordered forms can be studied in situ and in real time.

We offer various sample presentation methods allowing samples to be studied in solid, powder, suspension, cream or melt form. Our expert scientists have developed approaches to overcome common sample limitations such as inhomogeneity, preferred orientation and particle statistics, and extremely small amounts of material can be analyzed using these techniques.

Indexing
X-ray powder diffraction pattern indexing is the first step in the solution of a crystal structure from powder data but can also be used to determine if a given pattern represents a pure solid phase. The latter information is often sufficient to ensure product homogeneity if a crystal structure is unavailable. Our patented algorithm is an essential tool in the determination and confirmation of crystalline phase purity.

Calculation of an X-ray powder diffraction pattern from single crystal data provides important information about the homogeneity of a crystalline solid, as well as an unequivocal pattern for use as a standard. We use multiple software methods to calculate powder patterns from crystal coordinate files.

Once the crystal structure of a material has been determined, we can calculate an XRPD pattern. The calculated powder pattern provides information about homogeneity of the crystalline phase and serves as an unequivocal pattern for use as a standard for polymorph screening or quantitative analysis of multiphase samples. We can build parameters such as crystallite size, morphology and preferred orientation into the pattern calculation, providing insight into the microstructure of single-phase samples. Microstructural parameters often play a significant role in the physical and chemical properties of a sample.

Calculation of Powder Patterns
One of the more powerful features of pattern calculation is the ability to study disordering processes to identify relationships between crystalline phases and microcrystalline/amorphous phases. The subsequent calculated amorphous patterns can be used for precise crystallinity analysis if pure amorphous forms of the material are not available for measurement. We offer a wide range of tools for the calculation of powder patterns starting from crystal coordinate files, D and I files or reference patterns.

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Ion Exchange Chromatography
Price on request

To analyze your compounds, we offer a variety of chromatographic expertise and techniques including Ion chromatography for use in a wide variety of applications, including quantitation of API salts.

To analyze your compounds, we offer a variety of chromatographic expertise and techniques including Ion chromatography for use in a wide variety of applications, including quantitation of API salts.

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General Microbiology Services
Price on request

Using an outside, independent testing laboratory to prove compliance to regulatory requirements can free up your resources to concentrate on product development. Our experts bring many years of experience in the pharmaceutical, cosmetic and consumer industries, and we have handled a diverse and vast list of products and... Show more »

Using an outside, independent testing laboratory to prove compliance to regulatory requirements can free up your resources to concentrate on product development. Our experts bring many years of experience in the pharmaceutical, cosmetic and consumer industries, and we have handled a diverse and vast list of products and specifications. We also provide guidance to ensure your product receives the appropriate testing.

Our stand-alone facility is adjacent to the Container Center of Excellence and is dedicated to USP <51>, USP <61> and USP <62> testing that covers raw materials through finished products. The facility meets strict requirements to ensure we conduct FDA regulated, GMP testing. Our key pieces of equipment include world-class incubators, ovens and fume hoods.

USP <61> product safety testing is required to ensure that a product’s preparation complies with a preset specification for microbiological quality. In a similar function, USP <62> testing evaluates for specific pathogens including S. aureus, P. aeruginosa, E. coli, Salmonella species, Clostridium species, fungal organisms and a qualitative MPN for bile-tolerant gram negative bacteria. USP <51> is a preservative effectiveness test that is required for developmental formulations through finished products stability.

Our experts conduct tests that include:

  • USP <51> Antimicrobial Effectiveness Testing
  • USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
  • USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • USP <87> Biological Reactivity Tests, In Vitro USP <1231> Water for Pharmaceutical Purposes
  • Standard Methods – For the Examination of Water and Wastewater

We are an FDA-regulated, DEA-licensed, ISO 17025 and ISTA-certified contract service provider to the pharmaceutical, medical device, personal and consumer product industries. We offer analytical services for the testing of materials, finished products, container and package systems that enable you to meet the required quality standards established by key regulatory agencies.

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Solid-State Chemistry
Price on request

SOLID-STATE CHEMISTRY AND PARTICLE ENGINEERING

To maximize your success in drug substance development, we offer the ability to not only screen and select a form of optimal properties, but also to develop an understanding of the processes that ensure consistent material for development, clinical trials and... Show more »

SOLID-STATE CHEMISTRY AND PARTICLE ENGINEERING

To maximize your success in drug substance development, we offer the ability to not only screen and select a form of optimal properties, but also to develop an understanding of the processes that ensure consistent material for development, clinical trials and formulation.

Polymorphism

Polymorphism is the existence of a drug substance as two or more crystalline phases that have different arrangements and/or conformations of molecules in the crystal lattices. The presence of multiple polymorphs of the active pharmaceutical ingredient (API) is particularly challenging with solid, oral dosage drug products. Our experts can help you develop a robust crystallization process that consistently produces the desired polymorphic form of the bulk API.

In some cases, the physical and chemical properties of two solid forms of a drug vary dramatically and have a significant impact on pharmacokinetics, ease of manufacturing and dosage form stability. Properties that can differ among solid forms of a substance include color, solubility, crystal shape, water sorption and desorption properties, particle size and shape, hardness, drying characteristics, flow and filterability, compressibility and density.

In a drug substance, these variations in properties can lead to differences in dissolution rate, oral absorption, bioavailability, toxicology results and clinical trial results — and can affect both the safety and efficacy of the different solid forms. Furthermore, stability presents a special concern, since it is easy to inadvertently generate the wrong form at any point in the development process. Because energy differences between forms are usually relatively small, form interconversion is common and can occur during routine API manufacturing operations, drug product formulation, storage and use.

Encountering a new solid form during late stages of development can delay filing, and the appearance of a new form in drug product can lead to product withdrawal. For this reason, pharmaceutical manufacturers often select a drug substance polymorphic form that has the characteristics that will aid in the manufacture of the drug product formulation.

SOLID FORM SCREENING AND SELECTION

Addressing Polymorphism

A comprehensive study of polymorphism is required prior to NDA filing and is also necessary for intellectual property reasons. The pharmaceutical industry strives for improved efficiency in screening and selection of new chemical entities and in other areas where automation of process and data collection are appropriate.

To that end, an effective polymorph screening strategy relies on many experimental techniques in addition to solvent-mediated experimentation. We conduct our screens with the widest available experimental approaches, using common as well as proprietary search mechanisms. Proven to find more forms than standard screening strategies, our typical polymorph screen will employ:

  • Solvent-mediated screening
  • Fast evaporation
  • Slow evaporation
  • Mechanical techniques
  • Grinding
  • Thermal techniques
  • Computational pattern matching and TRIADS indexing analysis (U.S. Patents 7372941 and 8576985)

We believe X-ray powder diffraction is the best first method to discriminate solid forms and provide critical data for property determination and structural exploration. Additionally, by applying our computational models, we collect high-quality data to develop a deep structural understanding of the solid forms present and predict properties including relative thermodynamic stability, habit, density and electron density.

Salt Screening and Selection

Our salt screen involves a search for solid salts of ionizable drug products using sources of pharmaceutically acceptable counterions as well as knowledge of their properties, frequency of use in drug products and manufacturability. The desire to use a salt screen is usually due to poor drug substance properties such as lack of crystallinity, water solubility or stability. We design the salt screen based on the improvement desired and properties of the API, often using a tiered testing procedure to quickly identify the salts with optimum properties.

Solid Dispersion Screen

Poor aqueous solubility frequently occurs during the development of new drug products. To address solubility issues, we employ numerous techniques to search for and stabilize amorphous forms of drug substance. Amorphous materials are generally much more soluble than their crystalline counterparts, and we can often formulate them to be physically and chemically stable throughout the shelf life of the drug product.

Cocrystal Screen

Cocrystals incorporate guest molecules into a crystal lattice along with the API, changing the physical properties of the solid. Our cocrystal screens can identify new solid forms to solve physical property or bioavailability problems or to enable improved versions of existing drug products. We offer several levels of cocrystal screening to suit your research goals and budgets.

Crystallization of Difficult-to-Crystallize Materials

A common occurrence in drug development is poor crystallinity of a drug substance. A variety of problems can result from poor crystallinity, including hygroscopicity, poor handling properties, insufficient drug substance purity and chemical instability. Our crystallization screening strategy relies on the use of a wide variety of crystal growth conditions. We may also recommend alternative methods, such as crystallization via salt or cocrystal formation, for the purpose of growing single crystals for structure determination purposes or selection of a solid form for development.

Selection of Optimum Solid Form of Drug Substance

We have extensive experience in solid sample generation from microgram to multigram scale. Our expertise ranges from synthesis to salt formation to specialized techniques for making metastable polymorphic forms. We generate and characterize crystalline polymorphs, hydrates, solvates, desolvated solvates, salts and amorphous forms.

The properties of a solid that are important to its efficacy as a drug or excipient are highly dependent on the form of the solid. To help you secure FDA approval of an NDA, we use a tiered approach to select the optimal form of your specific drug for your specific application. Our approach includes salt selection, polymorph screening and cocrystal screening, and comparative property determinations. We can work with you to plan a research proposal aimed at selection of the best form of your compound for development and manufacture.

Thermodynamic Property Studies

We can help you easily visualize thermodynamic properties of polymorphic forms by using energy temperature diagrams. These diagrams plot relative enthalpies and free energies versus temperature. They may be constructed using thermal, solubility, infrared and/or interconversion data.

Chiral Material Analysis and Resolution

Like polymorphs, solid forms attained from racemic mixtures of a given chiral compound can be crystallographically distinct. A racemic mixture in the solid form may exist as a racemic compound (a racemate) whereby pairs of enantiomers are present within a single crystal structure, or a conglomerate, constituted from a physical mixture of two crystal phases in equivalent amounts, each containing single enantiomers. Our solids analysis capabilities enable determination of these relationships.

Drug Substance Specifications

The specifications established for bulk materials are crucial in designing appropriate analytical and quality control methods. By determining the properties and relative stabilities of solid forms, we set reasonable and appropriate bulk material specifications. Our scientists design methods, carry out sameness testing and develop and validate quantitative analytical methods to monitor the solid forms of manufactured substances.

We offer screening of resolving agents and design of crystallization processes for the resolution of racemic mixtures via diastereomeric salt formation. Our experts tailor recommendations of resolving agents for screening activities based on the functionalities of your API or intermediate. Our combination of solid state techniques and chiral chromatography capabilities allows for effective screening, selection and process development activities to deliver a scalable procedure for the resolution of racemic mixtures.

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Analytical Chemistry Services
Price on request

Decades of scientific expertise and access to market-leading technology enable us to meet your development and manufacturing needs, no matter how complex. AMRI’s highly experienced team offers a complete suite of chemistry-based testing services according to current USP, EP and JP compendial methods. Our internal quality assurance... Show more »

Decades of scientific expertise and access to market-leading technology enable us to meet your development and manufacturing needs, no matter how complex. AMRI’s highly experienced team offers a complete suite of chemistry-based testing services according to current USP, EP and JP compendial methods. Our internal quality assurance group routinely audits each of our areas for strict compliance with cGMP requirements. We are happy to consult with you to help you navigate the regulatory landscape and make your program a success.

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HPLC
High Performance Liquid Chromatography
Price on request

To analyze your compounds, we offer a variety of chromatographic expertise and techniques:

HPLC and UPLC/UHPLC instrumentation with a wide variety of detection capabilities (UV, DAD, RI, MS, MALS) to determine sample assay and purity of samples, along with quantitation for solubility, dissolution, diffusion and other techniques requiring quantitation

To analyze your compounds, we offer a variety of chromatographic expertise and techniques:

HPLC and UPLC/UHPLC instrumentation with a wide variety of detection capabilities (UV, DAD, RI, MS, MALS) to determine sample assay and purity of samples, along with quantitation for solubility, dissolution, diffusion and other techniques requiring quantitation

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Solid Form Screening
Price on request

To maximize your success in drug substance development, we offer the ability to not only screen and select a form of optimal properties, but also to develop an understanding of the processes that ensure consistent material for development, clinical trials and formulation.

Polymorphism

Polymorphism is the existence of a... Show more »

To maximize your success in drug substance development, we offer the ability to not only screen and select a form of optimal properties, but also to develop an understanding of the processes that ensure consistent material for development, clinical trials and formulation.

Polymorphism

Polymorphism is the existence of a drug substance as two or more crystalline phases that have different arrangements and/or conformations of molecules in the crystal lattices. The presence of multiple polymorphs of the active pharmaceutical ingredient (API) is particularly challenging with solid, oral dosage drug products. Our experts can help you develop a robust crystallization process that consistently produces the desired polymorphic form of the bulk API.

In some cases, the physical and chemical properties of two solid forms of a drug vary dramatically and have a significant impact on pharmacokinetics, ease of manufacturing and dosage form stability. Properties that can differ among solid forms of a substance include color, solubility, crystal shape, water sorption and desorption properties, particle size and shape, hardness, drying characteristics, flow and filterability, compressibility and density.

In a drug substance, these variations in properties can lead to differences in dissolution rate, oral absorption, bioavailability, toxicology results and clinical trial results — and can affect both the safety and efficacy of the different solid forms. Furthermore, stability presents a special concern, since it is easy to inadvertently generate the wrong form at any point in the development process. Because energy differences between forms are usually relatively small, form interconversion is common and can occur during routine API manufacturing operations, drug product formulation, storage and use.

Encountering a new solid form during late stages of development can delay filing, and the appearance of a new form in drug product can lead to product withdrawal. For this reason, pharmaceutical manufacturers often select a drug substance polymorphic form that has the characteristics that will aid in the manufacture of the drug product formulation.

Solid form screening, purposeful design of crystallization processes

Solid form screening and selection

• Crystallization of hard-to-crystallize materials
• Polymorphs, hydrates and solvates
• Multicomponent crystalline forms, salts / cocrystals
• Single crystal growth and structure determination
• Comprehensive physical properties investigation
• Establishing thermodynamic and kinetic relationships
• IP protection strategy of APIs

Problem-solving capabilities

• Supramolecular property modulation
• Batch-to-batch variability

Proprietary software

• Pattern matching
• Structure solution from X-ray powder diffraction (XRPD) data
• TRIADS XRPD indexing algorithm

Purposeful design and optimization of crystallization processes

• Targeting API with desired purity, crystal form and particle
characteristics
• Troubleshooting of existing processes for the final API or key intermediates
• Optimization of crystallization method for late stage candidates
• Chiral resolution via diastereomeric salt formation or
cocrystallization

Key differentiators

• Fit-for-purpose approach for each development stage
• Deliver reproducible downstream processes
• Ability to identify critical performance attributes of API for use in formulations

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Method development
Price on request

Method development with a phase-appropriate approach

  • Identification test methods to ensure the desired solid form is present
  • Limit test methods to determine if one or more minor solid forms are present
  • Quantitative methods to accurately determine the amount of forms

*Batch release and stability lot testing with... Show more »

Method development with a phase-appropriate approach

  • Identification test methods to ensure the desired solid form is present
  • Limit test methods to determine if one or more minor solid forms are present
  • Quantitative methods to accurately determine the amount of forms

Batch release and stability lot testing with issued certificate of analysis (CoA) for API and drug product

Troubleshooting and consulting services

  • Assessment of materials to help determine the origin of issues in API, drug product, and delivery devices
    • Batch-to-batch variability
    • Performance:
      • Dissolution, bioavailability and flow properties
    • Content uniformity
    • Presence of unknown materials

Batch Release and Stability Lot Testing

We provide the resources and flexibility to develop and improve analytical methods tailored to your specific needs. Our laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical ingredients, drug formulations, cosmetics, personal care products and raw materials.

Our scientists work under strict compliance with cGMP requirements and base our operations on detailed SOPs and stringent quality assurance practices. We provide effective and efficient communication through the duration of your project. You’ll receive a comprehensive report that details the procedures, analytical method, protocols, all test results, graphs and calculations and sample raw data (e.g., GC/HPLC chromatograms).

Our analytical techniques measure accuracy, precision, specificity, limit of detection/limit of quantitation (LOD/LOQ), linearity, range and robustness:

  • HPLC: UV variable wavelength, refractive index (RI), photo diode array detectors
  • GC: Flame ionization detector (FID), thermal conductivity detector (TCD), direct injection and headspace analysis - - - GC/MS: Identification of chemical structure and molecular weight determination based on the library of compounds - - Atomic absorption spectrophotometry (flame)
  • UV/visible spectroscopy
  • ICP-MS

We also have the capabilities to develop and validate a wide variety of other analytical methods for small molecules and biologics in either a liquid or solid state. Identification tests, limit tests, assays and quantitative analyses are four methods required for various stages of drug development. We develop these methods using analytical techniques such as LC, MS, NMR, XRPD, IR, Raman, thermal analysis, vapor sorption, particle size and microscopy.

Phase-appropriate method development is always a consideration to ensure that the necessary characteristics are evaluated for each method. We develop and validate all methods according to International Conference on Harmonisation (e.g., ICH Q2(R1), Q2B, and Q6A) and FDA guidelines.

Our chemometricians design experimentation for complex methods requiring principal component analysis or partial least squares regression. We also have significant experience with detecting and quantifying minor amounts of amorphous or crystalline forms in both drug substances and drug products. Our experts have successfully transferred many types of methods into our laboratory, and we can also transfer developed methods to your production site.

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Chemical Stability Testing
Price on request

Our industry-leading scientists conduct preclinical and clinical stability studies on drug substance and drug products through our full-service solid state and chromatography/dissolution groups. We develop chromatographic, dissolution and solid state methods for material assessment and conduct accelerated stress testing on site... Show more »

Our industry-leading scientists conduct preclinical and clinical stability studies on drug substance and drug products through our full-service solid state and chromatography/dissolution groups. We develop chromatographic, dissolution and solid state methods for material assessment and conduct accelerated stress testing on site with GMP ICH stability storage at AMRI sites or preferred vendors. Our experts guide you to the best solid form and dosage form for your API and help determine risks that may impact your development program.

Stress testing can reveal physical and chemical changes of the API or excipients that occur during processing and storage. We conduct high-temperature, high-humidity, light exposure, and mechanical (grinding and compression) stress studies to identify and quantitate physical and chemical changes. You can then assess risk and take precautions to control undesired changes in the API solid form.

In Vitro Comparative Analysis

We can evaluate the performance characteristics of various drug products in a laboratory setting. Using tools such as dissolution, diffusion and disintegration, we can assess abuse deterrence through alcohol-induced dose dumping and bioequivalence. In vitro bioequivalence studies can be performed for various non-absorbed drugs, topical and oral drugs, locally acting emulsions and suspensions, and transdermal patches. In vitro comparative studies can also be used to demonstrate equivalency in manufacturing process or site changes, equivalency in products with multiple strengths, and marketing advantage.

Dissolution

We perform dissolution testing to reveal differences in performance during drug product development and as a validated control method for release testing. Dissolution rates are highly dependent on the intrinsic properties of the API solid form (e.g., solubility) and the process parameters used for drug product manufacture (e.g., particle size distribution, tablet hardness and friability). Therefore, characterization of the dissolution rates of different formulations in various media can guide excipient selection and identify critical process control parameters to achieve the desired release profiles for an immediate, controlled or modified-release formulation. Our scientists have extensive experience developing and conducting dissolution studies for a broad range of drug products using both automated and manual sampling techniques.

Diffusion

To assess membrane permeability for various combination products, our scientists employ side-by-side diffusion. Franz vertical diffusion cells are used to evaluate drug release from semi-solid dosage forms.

Quantitation

We leverage a wide variety of quantitation tools to measure concentration of the API in different media from various in vitro comparative analysis techniques. In situ monitoring via a UV dip probe may be used for selected media. When possible, we develop a non-validated UV-VIS method. HPLC methods can also be developed and used. We perform these studies under controlled conditions using sufficient replicates to allow for calculation of statistics.

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Lot Release Testing
Price on request

We provide the resources and flexibility to develop and improve analytical methods tailored to your specific needs. Our laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical... Show more »

We provide the resources and flexibility to develop and improve analytical methods tailored to your specific needs. Our laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical ingredients, drug formulations, cosmetics, personal care products and raw materials.

Our scientists work under strict compliance with cGMP requirements and base our operations on detailed SOPs and stringent quality assurance practices. We provide effective and efficient communication through the duration of your project. You’ll receive a comprehensive report that details the procedures, analytical method, protocols, all test results, graphs and calculations and sample raw data (e.g., GC/HPLC chromatogram)

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Extractable and Leachable Testing
Price on request

Ensure that the materials your product comes into contact with do not affect its safety or efficacy, and that your product satisfies all FDA extractables and leachables (E&L) testing requirements.

AMRI’s multidisciplinary team of material scientists, analytical chemists, biomedical engineers, toxicologists and... Show more »

Ensure that the materials your product comes into contact with do not affect its safety or efficacy, and that your product satisfies all FDA extractables and leachables (E&L) testing requirements.

AMRI’s multidisciplinary team of material scientists, analytical chemists, biomedical engineers, toxicologists and biocompatibility specialists deliver E&L evaluations critical for successful product development and regulatory submissions. Our experts offer strategic vision and develop novel solutions, guiding you through the process to meet your needs in extractables/leachables and impurities.

We base our E&L studies on the recommendations of the Product Quality Research Institute’s Extractables and Leachables Working Group to the FDA, USP <1663>, USP <1664>, the Bio-Process Systems Alliance Extractables and Leachables Subcommittee, FDA container closure guidance, and ISO 10993 Part 18, Biological Evaluation of Medical Devices (chemical characterization of materials).

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Container Closure Integrity Testing
Price on request

Our container closure integrity experts provide accurate, sensitive and reliable data for definitive container closure integrity verification, especially for packages that demand the highest degree of product protection. We offer numerous state-of-the-art programs for assessing package system integrity, including all required... Show more »

Our container closure integrity experts provide accurate, sensitive and reliable data for definitive container closure integrity verification, especially for packages that demand the highest degree of product protection. We offer numerous state-of-the-art programs for assessing package system integrity, including all required instrumentation for deterministic test methods as outlined in USP <1207>.

Our services range from routine testing to in-depth method development and validation. The CCIT laboratory houses expert-level services specifically tailored to you and the package system.

Employ our CCIT programs to characterize packages and materials, optimize sealing parameters, evaluate package storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.

At our Container Testing Center of Excellence, the entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs so that you can be sure the right testing methods are deployed for your product.

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Packaging, Design & Testing
Price on request

As an independent, third-party laboratory, we are a trusted testing partner for distribution testing, packaging materials qualification and product testing. We provide technical expertise, market-leading technology and customized solutions for your unique needs. Our experts can help you better understand testing requirements,... Show more »

As an independent, third-party laboratory, we are a trusted testing partner for distribution testing, packaging materials qualification and product testing. We provide technical expertise, market-leading technology and customized solutions for your unique needs. Our experts can help you better understand testing requirements, available test options and how to execute packaging validation projects on time and on budget.

Our ISTA-certified, ISO 17025-accredited and fully cGMP lab specializes in package testing for a variety of industries. We provide a complete suite of testing services:

  • ASTM and ISTA distribution testing
  • Pharmaceutical package testing
  • Medical device package testing
  • Consumer product package testing
  • Shelf life and accelerated aging testing
  • Environmental conditioning
  • Packaging materials testing
  • Package integrity testing
  • Package strength testing
  • Package labeling
  • Environmental testing
  • Forced degradation study
  • Pharmaceutical Package Testing

Drug product packaging must be able to withstand the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity and protects the primary product. Our services help your life-saving therapies reach the patient in usable form.

Medical Device Package Testing

Per ISO 11607 standards, medical device manufacturers are required to ensure the integrity of their sterile medical device packaging. Medical device package validation includes package stability testing, performance/dynamics testing and strength and integrity testing following the guidelines of ISO 11607.

Consumer Product Package Testing

We provide distribution testing of packaging designs per ISTA and ASTM methods to eliminate the headaches of damaged goods and lost business before they happen. Our services simulate the conditions that consumer products experience throughout the distribution cycle: vibrations, stacking, dropping, baking or freezing.

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Medical Device Testing
Price on request

We are your one-stop source for medical device testing and validation — for products, materials and packaging. Our expert engineers and technicians provide reliable, quality-assured testing services and documentation throughout every step of the critically important testing and validation process.

A leader and innovator in... Show more »

We are your one-stop source for medical device testing and validation — for products, materials and packaging. Our expert engineers and technicians provide reliable, quality-assured testing services and documentation throughout every step of the critically important testing and validation process.

A leader and innovator in medical device testing, we offer solutions to medical device development engineers, QA and regulatory affairs professionals to ensure your devices meet all regulatory agency requirements and the highest industry standards.

Medical device manufacturers are required to obtain 510(K) approval on each medical device package. We perform a variety of testing services to ensure compliance with the integrity of the device.

Drug Delivery Device Testing

We have a dedicated unit focused on providing support and testing for compliance with ISO 11608. Our experts perform standard and customized functional, mechanical, force, dimensional/metrology and dose delivery/accuracy testing for drug delivery devices. Testing can be designed to support all life cycle phases of your combination products from early concept and preclinical testing through final product qualification and management of ongoing commercial program support. The laboratory includes on-site preconditioning necessary for testing according to ISO 11608 – Needle-Based Injection Systems for Medical Use.

ISO 11607 Medical Device Package Validation

Our ISTA and ISO 17025-certified package testing laboratory provides medical device package validation testing according to ISO 11607, the principle guidance for validating terminally sterilized medical device packaging. We can help with the interpretation of the complex ISO regulations and advise you on how to execute your packaging validation projects on time and on budget.

ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging. Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to the anticipated environmental and dynamic stresses that the packaging system may encounter. Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure.

We provide standard testing for a wide range of sterile barrier medical packaging:

  • Visual Inspection: ASTM F1886, Determining Integrity of Seals for Flexible Packaging by Visual Inspection
  • Internal Pressurization: ASTM F2096, Detecting Gross Leaks in Packaging by Internal Pressurization (bubble test)
  • Vacuum Leak: ASTM D3078, Determination of Leaks in Flexible Packaging by Bubble Emission Integrity/Dye
  • Penetration: ASTM F1929, Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Integrity/Dye
  • Penetration: ASTM F3039, Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye
  • Penetration Seal Strength: ASTM F88, Seal Strength of Flexible Barrier Materials
  • Seal Strength: ASTM F1140, Internal Pressurization Failure Resistance of Unrestrained Packages (for medical application)
  • Seal Strength: ASTM F2054, Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
  • Tensile Properties: ASTM D882, Tensile Properties of Thin Plastic Sheeting
  • Tear Resistance: ASTM D1922, Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
  • Puncture: ASTM D3420, Pendulum Impact Resistance of Plastic Film
  • Puncture: ASTM F1306, Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
  • Puncture: ASTM D1709, Impact Resistance of Plastic Film by the Free-Falling Dart Method
  • Performance: ASTM D4169, Performance Testing of Shipping Containers and Systems
  • Performance: ISTA Series 1, 2 and 3 Distribution Tests
  • Aging: ASTM F1980, Accelerated Aging of Sterile Barrier Systems for Medical Devices

Mechanical and Functional Device Testing

Prior to marketing your finished product, it may be necessary to ensure your device and container designs meet specific expectations. We offer mechanical testing that provides data pertaining to the suitability and functionality of the materials used for the intended application.

Our metrology laboratory is FDA registered and audited, ISO 17025 and ISTA certified and includes state-of-the-art equipment such as digital micrometers and gauges, optical comparators, Instron force measurement equipment, torque meters and digital microscopes. We can develop custom fixtures for complex measurements and components.

Our experts subject your devices and containers to changes in temperature, tension, compression, load and other conditions. In addition, we evaluate materials and components to determine whether their physical properties and functionality are manufactured to the specifications designated by package engineers.

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Microbiology Testing
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Microbiology

  • Water and in-process bioburden and pathogen testing
  • Microbial Limits of Non-Sterile Products
    • Enumeration
    • Specified / Objectionable organism
  • Antimicrobial / Preservative Effectiveness testing
    • Stability / Formulation / R&D Support
  • Environmental Monitoring

Microbiology

  • Water and in-process bioburden and pathogen testing
  • Microbial Limits of Non-Sterile Products
    • Enumeration
    • Specified / Objectionable organism
  • Antimicrobial / Preservative Effectiveness testing
    • Stability / Formulation / R&D Support
  • Environmental Monitoring
    • Process / System Validation
    • Program Design
    • Compressed Air
    • Cleanroom / Controlled Environments
  • Biological Indicators
    • Processing
    • Population Verification
  • Method Development / Suitability / Validation
  • Purified Water System Validation
  • Cleaning Validation
  • Disinfectant Studies

Biology

  • Bacterial Endotoxin Testing
    • LAL
    • Method Development / Suitability / Validation
  • Biological Reactivity
    • Tests In Vitro
      • ISO and USP
    • Tests In Vivo
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Gas Chromatography (GC)
Gas Chromatography
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UPLC
Ultra performance liquid chromatography
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Chromatography
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  • Reversed-phase HPLC
  • Ion exchange HPLC
  • Size exclusion w/ MALS and RID
  • Reversed-phase HPLC
  • Ion exchange HPLC
  • Size exclusion w/ MALS and RID
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Biochemical Assays
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• Isolation and purification
• Identification and authentication
• Protein crystallization
• Electrophoresis
• Light scattering
• Protein sequence & composition
• LAL Endotoxin

• Isolation and purification
• Identification and authentication
• Protein crystallization
• Electrophoresis
• Light scattering
• Protein sequence & composition
• LAL Endotoxin

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ICP-MS
Inductively Coupled Plasma Mass Spectrometry
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Thermogravimetric Analysis (TGA)
Thermogravimetric Analysis
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Karl Fischer Titration
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Microscopy
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  • Polarized light
  • SEM: standard / environmental / EDX • Hot / cold stage microscopy
  • Vibrational
  • Polarized light
  • SEM: standard / environmental / EDX • Hot / cold stage microscopy
  • Vibrational
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Thermal Analysis Services
Price on request
  • DSC: standard, modulated, nanoDSC
  • TGA, TG-IR
  • Hot bench
  • Microcalorimetry: solution and isothermal
  • Melting point

THERMAL ANALYSIS AND CALORIMETRY

We monitor thermochemical events and weight loss as a function of temperature to achieve insight into solid form characteristics, mechanisms of polymorphic... Show more »

  • DSC: standard, modulated, nanoDSC
  • TGA, TG-IR
  • Hot bench
  • Microcalorimetry: solution and isothermal
  • Melting point

THERMAL ANALYSIS AND CALORIMETRY

We monitor thermochemical events and weight loss as a function of temperature to achieve insight into solid form characteristics, mechanisms of polymorphic transformations and solid state degradation pathways. To analyze these properties of bulk and formulated solid products, we use modern differential scanning calorimetry (DSC) and thermal gravimetric analysis (TGA).

DSC, Modulated DSC

Differential scanning calorimetry is one of the most widely used thermal analysis techniques for the characterization of pharmaceutical solids. We measure thermal events such as melting, recrystallization, decomposition and glass transitions. In addition, we can perform quantitative mixture analysis (i.e., determination of polymorph mixtures). Modulated DSC offers expanded capabilities by allowing for the measurement of heat capacities and the characterization of reversible and nonreversible thermal transitions.

Melting Point

Melting point determination is an important aspect of polymorph analysis in terms of stability. We provide melting point determination per the various methods outlined in the USP.

Thermogravimetric Analysis and Thermogravimetric/Infrared Analysis

We conduct thermogravimetric analysis to measure the thermally induced weight loss of a sample as a function of temperature. In conjunction with DSC and hot-stage optical microscopy, TGA provides an excellent approach to the determination of thermal properties of the pharmaceutical material. Extending the TGA technique to thermogravimetric/infrared analysis (TG/IR) provides the ability to not only measure thermally induced weight loss, but also to chemically identify the volatile component during each weight loss step. As a volatile component evolves from the sample in the TG furnace, it is swept into a gas-phase IR cell for spectroscopic analysis and potential chemical identification. TG/IR is an ideal technique for solvate and hydrate analysis.

Hot-Stage Optical Microscopy

Hot-stage optical microscopy is a technique we use in conjunction with differential scanning microscopy, thermal gravimetric or thermal gravimetric/infrared to characterize the thermal properties of your pharmaceutical solid. We provide analysis with two different hot-stages that allow for controlled temperature experiments from -196 to 600 °C. We can also capture video or digital images of visual thermal events such as melting, recrystallization or volatilization.

Isothermal Microcalorimetry

We perform isothermal microcalorimetry to study a wide variety of physical and chemical processes. It can be used to evaluate excipient compatibility, amorphous content, degradation rate, relative stability of polymorphs and any other process associated with a change in enthalpy. Our instrumentation includes specialized accessories that allow control of the relative humidity and oxygen content of the sample environment.

Solution Calorimetry

We use solution calorimetry to measure the heat of a solution of a solute as it dissolves in a solvent. This measurement can be used for detection and quantification of polymorphs and amorphous material, determination of the relative stability of polymorphs and for monitoring dissolution processes. Our instrumentation includes both semi-adiabatic and isothermal solution calorimeters.

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X-Ray Diffraction
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• Standard, VT and RH
• Indexing
• Single crystal structure solution

• Standard, VT and RH
• Indexing
• Single crystal structure solution

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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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Spectroscopy
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  • IR: FT and mapping
  • NIR imaging
  • Raman: FT and mapping, solution probe
  • NMR: solids and liquids
  • UV-Vis: cuvette and plate reader
  • Fluorescence
  • Mass: QTrap LC-MS/MS, MALDI-TOF, Q-TOF
  • IR: FT and mapping
  • NIR imaging
  • Raman: FT and mapping, solution probe
  • NMR: solids and liquids
  • UV-Vis: cuvette and plate reader
  • Fluorescence
  • Mass: QTrap LC-MS/MS, MALDI-TOF, Q-TOF
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Dose Delivery Testing
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Isothermal Microcalorimetry (IMC)
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Isothermal Microcalorimetry

We perform isothermal microcalorimetry to study a wide variety of physical and chemical processes. It can be used to evaluate excipient compatibility, amorphous content, degradation rate, relative stability of polymorphs and any other process associated with a change in enthalpy. Our... Show more »

Isothermal Microcalorimetry

We perform isothermal microcalorimetry to study a wide variety of physical and chemical processes. It can be used to evaluate excipient compatibility, amorphous content, degradation rate, relative stability of polymorphs and any other process associated with a change in enthalpy. Our instrumentation includes specialized accessories that allow control of the relative humidity and oxygen content of the sample environment.

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Trace Metal Analysis
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We leverage our capabilities in inductively coupled plasma mass spectrometry (ICP-MS) to detect trace metals at levels as low as parts per trillion. We have the capability to perform USP <232> and USP <233> testing, including heavy metals testing and testing on drug substances, excipients, drug products and dietary... Show more »

We leverage our capabilities in inductively coupled plasma mass spectrometry (ICP-MS) to detect trace metals at levels as low as parts per trillion. We have the capability to perform USP <232> and USP <233> testing, including heavy metals testing and testing on drug substances, excipients, drug products and dietary supplements.

For improved sample preparation, we use the UltraWAVE microwave digestion apparatus for hard-to-solubilize samples, as well as techniques such as aqua regia and hydrofluoric acid.

Our ICP-MS can detect and measure the following metals:
Aluminum, arsenic, antimony
Barium, bismuth
Cadmium, cobalt, calcium, copper
Germanium, gold
Indium Iron Lead, lithium Magnesium, manganese, mercury, molybdenum
Nickel
Palladium, platinum
Potassium
Selenium
Silver, sodium
Tin, titanium, thallium
Yttrium
Zinc, zirconium

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Single Crystal X-Ray Diffraction
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An unequivocal method of solid form identification, and one preferred by the FDA when possible, is single crystal X-ray structure determination. An attempt should be made to obtain a single-crystal structure on all suitably crystalline new drug candidates. Our scientists employ the most modern methods, including a state-of-the-art... Show more »

An unequivocal method of solid form identification, and one preferred by the FDA when possible, is single crystal X-ray structure determination. An attempt should be made to obtain a single-crystal structure on all suitably crystalline new drug candidates. Our scientists employ the most modern methods, including a state-of-the-art Rigaku SuperNova diffractometer equipped with a micro-focus X-ray source and HPAD detector. This allows the determination of structures using smaller crystals than are required for conventional equipment.

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Accelerated Aging
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NIR Spectroscopy
Near-Infrared Spectroscopy
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Near infrared (NIR) spectroscopy offers many of the advantages of FTIR and Raman but overcomes some of the limitations. NIR offers the same advantage over FTIR as Raman in that neither glass nor water interferes with the analysis and may also allow for in situ sampling in various packaging configurations. NIR spectra result from... Show more »

Near infrared (NIR) spectroscopy offers many of the advantages of FTIR and Raman but overcomes some of the limitations. NIR offers the same advantage over FTIR as Raman in that neither glass nor water interferes with the analysis and may also allow for in situ sampling in various packaging configurations. NIR spectra result from absorption of overtones and combination bands from the mid infrared region; therefore, chemical or physical differences detected by FTIR also affect NIR data.

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Humidity Testing
Price on request

Controlled relative humidity (RH)-XRPD
Relative humidity chambers

Controlled relative humidity (RH)-XRPD
Relative humidity chambers

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Rietveld Refinement
Price on request

The Rietveld method is a computational treatment of diffraction data that separates overlapping data from a typical XRPD pattern and allows accurate determination of the structure of a compound. We use this method to address various problems including quantitation using XRPD patterns with high degrees of overlap.

The Rietveld method is a computational treatment of diffraction data that separates overlapping data from a typical XRPD pattern and allows accurate determination of the structure of a compound. We use this method to address various problems including quantitation using XRPD patterns with high degrees of overlap.

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Spectrophotometry
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Protein Expression
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Other Mass Spectrometry Methods
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Toxicology
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Physical Analysis Methods
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Engineering & Devices
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Biology
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Consumer Product Testing Services
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Computational & Statistical Analysis
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Environmental Science
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Lab and Facility Services
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Cells and Tissues
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Packaging
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Product Quality Control and Assurance
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Medical Devices & Diagnostics
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Materials Science
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Purification Services
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Project Management & Consulting Services
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Pharmacology & Toxicology
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Microbiology, Virology, and Parasitology
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Liquid Chromatography
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Experimental Design
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Antimicrobial Activity Testing
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Testing of Cell Lines
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Chemistry and Materials
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Product Development & Testing
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Biomolecular Interaction Analysis
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Water Quality Monitoring
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Cleaning & Sterilization Services
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Protein Services
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Infrared spectroscopy services
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Biochemistry & Molecular Biology
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Microbiology Assays
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Material Characterization Services
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Structural Biology
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Environmental & Geological Sciences
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Protein Characterization Services
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Formulation & Manufacturing
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