V0zpu7pvs0xeeyzp2qoq inbi

Integrity Bio

ic No Reviews Yet
ic No Completed Orders
Camarillo, California, US

About Integrity Bio

Integrity Bio is a contract development and manufacturing organization focused on the formulation and GMP filling of biologics. We have formulated over 150 biologics including vaccines, antibodies, proteins, and peptides for more than 75 firms. Integrity Bio specializes in hard-to-formulate products in liquid... Show more »

Integrity Bio is a contract development and manufacturing organization focused on the formulation and GMP filling of biologics. We have formulated over 150 biologics including vaccines, antibodies, proteins, and peptides for more than 75 firms. Integrity Bio specializes in hard-to-formulate products in liquid and lyophilized forms.

In addition, Integrity Bio has developed proprietary products to solve development challenges or extend the product lifecycle. For lyophilized products, Integrity Bio offers LyoTip, a simple to use reconstitution system that allows one step reconstitution and injection without complex mixing and set up procedures. www.lyotip.com

For products only stable at lower concentration or in lyophilized state, Integrity has recently patented high concentration formulation (HCF) technology that can convert lyophilized and liquid IV drugs into ready to use liquid subcutaneous concentrations.

Integrity Bio, Inc. was originally founded as Integrity Biosolution in 2003 by Dr. Byeong Chang

Show less

Our Services (87)


ic

Particle Analysis and Characterization

Price on request

Subvisible Particle Analysis

The potential immunogenicity of particles ranging from nanometer to micron sizes in biotherapeutics has been a growing area of discussion between regulators and industry. Both the USP and Ph.Eur. currently require biopharmaceutical products to quantify subvisible particles larger than 10 µm and 25... Show more »

Subvisible Particle Analysis

The potential immunogenicity of particles ranging from nanometer to micron sizes in biotherapeutics has been a growing area of discussion between regulators and industry. Both the USP and Ph.Eur. currently require biopharmaceutical products to quantify subvisible particles larger than 10 µm and 25 µm, respectively. However, clinical and laboratory data have yet to conclusively define thresholds for immunogenicity.

Due to the complex milieu of subvisible particles, sample preparation and the method of analysis can affect the accuracy of:

  • Particle Sizing
  • Particle Counting
  • Particle Classification

Consequently, multiple orthogonal techniques are strongly recommended for subvisible particle analysis. Integrity Bio, Inc. offers multiple orthogonal techniques for subvisible particle characterization:

  • Light Obscuration
  • Flow Imaging Microscopy
  • Dynamic Light Scattering

Light Obscuration

USP <788> and USP <789> particle testing via light obscuration uses a HIAC liquid particle counter for quantitation of particles greater than or equal to 10 µm and 25 µm. However, there are limitations with this technique:

  • Cannot distinguish between proteinaceous and non-proteinaceous particles (air bubbles, silicone oil, etc.)
  • Difficulty in detecting translucent particles

Flow Imaging Microscopy

Flow imaging microscopy can be performed using either Micro-Flow Imaging™ or FlowCam™.

  • Captures digital images of particles
  • Can acquire particle counts and morphological data
  • Highly sensitive technique able to detect translucent particles
  • Can screen for particles of specific morphologies or screen against particles that are not of interest, such as air bubbles or silicone oil droplets

Dynamic Light Scattering

Dynamic light scattering is another orthogonal technique for subvisible particle analysis.

  • Measures particle mass, size, and size distribution of molecules and particles
Show less

ic

Drug Preformulation

Price on request

Preformulation characterization studies generally include accelerated stability (stress) studies, stability-indicating analytical method development, and other physiochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. The following table shows examples... Show more »

Preformulation characterization studies generally include accelerated stability (stress) studies, stability-indicating analytical method development, and other physiochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. The following table shows examples of preformulation studies.

The objectives of the pre-formulation research will include:

  • Understanding the pharmaceutically significant physicochemical properties
  • Estimating product’s stability when exposed to various common stresses
  • Developing stability-indicating assays for major degradation products
  • Deciding upon a lyophilized or liquid formulation for initial clinical studies
  • Finalizing a formulation development research protocol (matrix of buffer, pH, stabilizer, tonicity modifier; analytical methods; etc.)

Example of Integrity Bio’s preformulation study Package (2-3 months)

A preformulation study will perform systematic research designed to examine the physicochemical properties of product candidate that may be important in formulation development. During such a study, the product candidate will be exposed to various stresses, key degradation products will be identified, and appropriate stability-indicating assays will be developed. The product candidates will be prepared in well defined formulation matrix, exposed to relevant stresses, and analyzed by stability indicating assays.

Stability indicating analytical methods, either developed by Integrity Bio or transferred from clients, will be used to determine the degradation products. We recommend using orthogonal methods to assess comprehensive stability profile of each product.

Analytical Methods

  • Stability Indicating Assays and Stress Testing: orthogonal physical and chemical degradation products
  • Structural analysis: CD, FTIR, fluorescence, thermal denaturation
  • HPLC: size-exclusion, ion-exchange, reversed-phase, hydrophobic interaction
  • Electrophoresis: SDS-PAGE, Protein Analyzer, Capillary electrophoresis
  • Particle analysis: Microflow imaging (MFI), FlowCam, DLS, HIAC
  • Viscosity or syringeability: Instron
  • Biological activity

Deliverables

  • Key product stability profile: stress, degradation products, stability indicating assays
  • Formulation sweet spot: pH, ionic strength, surfactant, other necessary stabilizer(s)
  • Liquid Formulation: refrigerated or frozen
  • Lyophilized formulation: refrigerated
  • Short term stability study result (both accelerated and real time)
Show less

ic

Biopharmaceutical Process Development

Price on request

During process development, we quickly identify and optimize process conditions and parameters. Various formulations related process development can be conducted at Integrity Bio including:

  • Ultrafiltration/diafiltration (UF/DF)
  • Product concentration
  • Sterile filtration
  • Buffer characterization
  • Aseptic fill/finish process... Show more »

During process development, we quickly identify and optimize process conditions and parameters. Various formulations related process development can be conducted at Integrity Bio including:

  • Ultrafiltration/diafiltration (UF/DF)
  • Product concentration
  • Sterile filtration
  • Buffer characterization
  • Aseptic fill/finish process development
  • Temperature sensitive formulations
  • Process scale up
  • Engineering runs
  • Lyophilization cycle development

A properly developed lyophilization cycle not only reduce the cost associated with the drying process but also can protect the drug product during drying process and subsequent storage.

Lyophilization process development requires good understanding of the following parameters:

  • Product integrity during lyophilization: stability indicating assays, FTIR structural analysis
  • Physical properties of formulations under frozen condition, e.g., glass transition temperature or collapse temperature, re-crystallization or devitrification, and eutectic melting temperature of excipient in the unfrozen fraction
  • Presence of key stabilizers, e.g., surfactant, water-replacing glass formers
  • Potential pH change during freezing due to selective crystallization of buffer components
  • Phase separation of key ingredients during freezing
  • Desired final moisture content
  • Vapor pressure of ice at desired product temperature
  • Lyophilizer capacity and limitation
  • Scale up to GMP lyophilization
  • Validation of processes
  • Preparation of draft manufacturing protocols and templates of batch records

Each of the following steps can be optimized to achieve the most efficient cycle with good product integrity:

  • Freezing and subsequent annealing
  • Primary drying
  • Transition to the secondary drying
  • Secondary drying

Integrity Bio has two laboratory scale lyophilizers and one GMP lyophilizer for process development, scale up, engineering run, and GMP manufacturing of final drug products. Other supporting analytical equipment including subambient DSC and FTIR are crucial for proper cycle development.

Deliverables

  • Clinical Manufacturing Process: develop a scalable formulation process to take the laboratory method to clinical production
  • Lyophilization Scale-Up: expertise to ensure the method piloted in the laboratory effectively scales to clinical manufacturing
  • Array Based Designs: investigate a broad parameter space for route selection and process development for catalytic and other organic transformations
  • Crystallization Development: identify key organic solvents and solvent systems which yield optimal solubility curves
  • Validation reports and draft manufacturing protocols
Show less

ic

Analytical Method Development

Price on request

Good formulation attributes can be achieved only when informative analytical methods are available. Results obtained from analytical methods specifically developed for the interested protein will be also used to present the quality of the formulation. It is important to wisely select analytical methods that are both relevant and... Show more »

Good formulation attributes can be achieved only when informative analytical methods are available. Results obtained from analytical methods specifically developed for the interested protein will be also used to present the quality of the formulation. It is important to wisely select analytical methods that are both relevant and sensitive to the specific issues. Listed below are examples of analytical methods that Integrity Bio is using for formulation development of protein therapeutics.

Structural analyses: Measure the secondary, tertiary, and quaternarystructure of biologically active proteins,

  • Circular Dichroism (CD)
  • Fourier Transformed Infrared Spectroscopy (FTIR)
  • Fluorescence Spectroscopy
  • Differential Scanning Calorimetry (DSC)

HPLC methods: HPLC methods with variety of high resolution analytical columns represent the most effective and efficient means of monitoring various degradation of protein therapeutics.

  • Size-exclusion chromatography
  • Ion-exchange (cation-exchange, anion-exchange) chromatography
  • Reversed phase chromatography
  • Hydrophobic interaction chromatography
  • Various detectors: UV, fluorescence, reflective Index, evaporative light scattering, mass spectrometry

Electrophoresis: Separation of impurities based on both charge and mass makes electrophoresis an excellent orthogonal method

  • Capillary Electrophoresis (CE)
  • Sodium dodecyl sulfate electrophoresis (SDS-PAGE)
  • Protein Analyzer

Particle Analysis: Particles represent a unique challenge in the stability of protein therapeutics as only few micrograms of degraded protein is sufficient to generate unacceptably large number of particulates. As a result,a formulation with good purity profile by HPLC methods can be rejected by visual inspection if it contains particulates. Various analytical methods are available dependent on the size of particulates.

  • Microflow Imaging (MFI): excellent for sub-visible particles
  • Light scattering (dynamic and static)
  • Analytical Ultrafiltration (AUC)
  • HIAC Liquid Particle Counter

Viscosity: Good measurement of viscosity may be required for manufacturing process as well as injection through narrow bore needles.

  • Viscometer
  • Instron – Syringeability study

Biological activity assays

Other useful analytical methods:

  • Subambient differential scanning calorimetry (characterization of frozen formulations)
  • DSC for the glass transition temperature of dry powder
  • Karl Fisher moisture titrator
Show less

ic

Custom Manufacturing

Price on request

Integrity Bio, Inc. performs contract cGMP manufacturing services including aseptic filling of parenteral products for stability, preclinical, and clinical studies.

Our state of the art manufacturing facility is located in Camarillo, California in close proximity to our Research and Development Laboratories and houses our Quality... Show more »

Integrity Bio, Inc. performs contract cGMP manufacturing services including aseptic filling of parenteral products for stability, preclinical, and clinical studies.

Our state of the art manufacturing facility is located in Camarillo, California in close proximity to our Research and Development Laboratories and houses our Quality Control Laboratories, Stability Laboratory, and Clean Room Manufacturing Suites with Lyophilization manufacturing capability.

Operating within a cGMP environment under centralized Quality Assurance Systems managed by our experienced and dedicated Quality Assurance Department, we aspire to become your first choice for contract manufacturing and are committed to our legacy clients to provide superior quality which is embedded into all aspects of our culture, philosophies, and operations.

We fill a variety of formats including vials, syringes (prefilled), cartridges, bottles, and our container closure system Lyotip.

We offer the rapid delivery of products conforming to California FDA, US FDA, and EU standards. Our highly qualified and experienced professionals provide a pleasant working experience and environment for all of our clients.

Show less

ic

Product Stability Testing

Price on request
  • Reliable stability indicating test methods with cGMP testing capabilities
  • Scientifically sound and timely method transfers
  • Full QC analytical development and qualification/validation
  • Reliable stability indicating test methods with cGMP testing capabilities
  • Scientifically sound and timely method transfers
  • Full QC analytical development and qualification/validation
Show less

ic

Fill/Finish Processing

Price on request

Integrity Bio, Inc. performs contract cGMP manufacturing services including aseptic filling of parenteral products for stability, preclinical, and clinical studies.

Our state of the art manufacturing facility is located in Camarillo, California in close proximity to our Research and Development Laboratories and houses our Quality... Show more »

Integrity Bio, Inc. performs contract cGMP manufacturing services including aseptic filling of parenteral products for stability, preclinical, and clinical studies.

Our state of the art manufacturing facility is located in Camarillo, California in close proximity to our Research and Development Laboratories and houses our Quality Control Laboratories, Stability Laboratory, and Clean Room Manufacturing Suites with Lyophilization manufacturing capability.

Operating within a cGMP environment under centralized Quality Assurance Systems managed by our experienced and dedicated Quality Assurance Department, we aspire to become your first choice for contract manufacturing and are committed to our legacy clients to provide superior quality which is embedded into all aspects of our culture, philosophies, and operations.

We fill a variety of formats including vials, syringes (prefilled), cartridges, bottles, and our container closure system Lyotip.

We offer the rapid delivery of products conforming to California FDA, US FDA, and EU standards. Our highly qualified and experienced professionals provide a pleasant working experience and environment for all of our clients.

Show less

ic

Lyophilization

Price on request

Integrity Bio offers cGMP facilities to manufacture sterile lyophilized formulations. The lyophilization facility at Integrity Bio operates under class 100 conditions and is capable of developing, manufacturing, and validating customized lyo cycles. Our lyophilization batch sizes can range from 150 to 5000 vials depending on your... Show more »

Integrity Bio offers cGMP facilities to manufacture sterile lyophilized formulations. The lyophilization facility at Integrity Bio operates under class 100 conditions and is capable of developing, manufacturing, and validating customized lyo cycles. Our lyophilization batch sizes can range from 150 to 5000 vials depending on your required presentation. We can conduct Engineering Runs to monitor assure a smooth transfer or development of your product specific cycles.

In order to increase efficiency, precision, and control of the lyophilization process, Integrity Bio incorporates NIST traceable calibration programs, and robust maintenance programs for all equipment and utilities.

We also provide lyophilization cycle development services with over 30 years of collective cycle development experience.

Show less

ic

Tablet Manufacturing

Price on request
Request a quote for more information about this service.

ic

Product Quality Control

Price on request
Request a quote for more information about this service.

ic

Aerosol Manufacturing

Price on request
Request a quote for more information about this service.

ic

Parenteral Manufacturing

Price on request
Request a quote for more information about this service.

ic

Sterile Manufacturing

Price on request
Request a quote for more information about this service.

ic

Clinical Laboratory Services

Price on request
Request a quote for more information about this service.

ic

Clinical Trials Supply Manufacturing

Price on request
Request a quote for more information about this service.

ic

Cartridge Filling

Price on request
Request a quote for more information about this service.

ic

Pharmaceutical Manufacturing

Price on request
Request a quote for more information about this service.

ic

Antibody-Drug Conjugate (ADC) Manufacturing

Price on request
Request a quote for more information about this service.

ic

Batch Release Testing

Price on request
Request a quote for more information about this service.

ic

HPLC

High Performance Liquid Chromatography
Price on request
Request a quote for more information about this service.

ic

High Throughput Screening (HTS)

Price on request
Request a quote for more information about this service.

ic

Pharmaceutical Formulation

Price on request
Request a quote for more information about this service.

ic

Vial Filling

Price on request
Request a quote for more information about this service.

ic

Pre-Filled Syringe Manufacturing

Price on request
Request a quote for more information about this service.

ic

Feasibility Studies

Price on request
Request a quote for more information about this service.

ic

Endotoxin Testing

Price on request
Request a quote for more information about this service.

ic

Drug Discovery

Price on request
Request a quote for more information about this service.

ic

Drug Development

Price on request
Request a quote for more information about this service.

ic

Drug Delivery Systems

Price on request
Request a quote for more information about this service.

ic

Downstream Processing

Price on request
Request a quote for more information about this service.

ic

Dosage Form Development

Price on request
Request a quote for more information about this service.

ic

Contract Research

Price on request
Request a quote for more information about this service.

ic

Contract Packaging

Price on request
Request a quote for more information about this service.

ic

Contract Development And Manufacturing Organization (CDMO)

Price on request
Request a quote for more information about this service.

ic

Consulting

Price on request
Request a quote for more information about this service.

ic

Chemistry, Manufacturing and Controls (CMC)

Price on request
Request a quote for more information about this service.

ic

Central Lab Services

Price on request
Request a quote for more information about this service.

ic

Biopharmaceutical Development

Price on request
Request a quote for more information about this service.

ic

Drug Discovery & Development

Price on request
Request a quote for more information about this service.

ic

Bioprocessing, Disposable/Single-Use

Price on request
Request a quote for more information about this service.

ic

Protein Purification

Price on request
Request a quote for more information about this service.

ic

Bioprocess Development and Scale-Up

Price on request
Request a quote for more information about this service.

ic

Biopharmaceutical Manufacturing

Price on request
Request a quote for more information about this service.

ic

Clinical Research

Price on request
Request a quote for more information about this service.

ic

Assay Development

Price on request
Request a quote for more information about this service.

ic

Aseptic Processing

Price on request
Request a quote for more information about this service.

ic

Solubility and Dissolution Testing

Price on request
Request a quote for more information about this service.

ic

Liquid Chromatography (LC)

Price on request
Request a quote for more information about this service.

ic

Analytical Method Validation

Price on request
Request a quote for more information about this service.

ic

Analytical Chemistry Services

Price on request
Request a quote for more information about this service.

ic

Accelerated Stability Testing

Price on request
Request a quote for more information about this service.

ic

Business Development Consulting

Price on request
Request a quote for more information about this service.

ic

Chemistry and Materials

Price on request
Request a quote for more information about this service.

ic

Manufacturing Services

Price on request
Request a quote for more information about this service.

ic

Packaging Services

Price on request
Request a quote for more information about this service.

ic

Product Development, Testing, and Packaging

Price on request
Request a quote for more information about this service.

ic

ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request
Request a quote for more information about this service.

ic

Biochemistry & Molecular Biology

Price on request
Request a quote for more information about this service.

ic

Microbial Fermentation and Bioprocessing

Price on request
Request a quote for more information about this service.

ic

Process Consulting

Price on request
Request a quote for more information about this service.

ic

Synthetic Chemistry

Price on request
Request a quote for more information about this service.

ic

Separation/Purification Services

Price on request
Request a quote for more information about this service.

ic

Hit Identification

Price on request
Request a quote for more information about this service.

ic

Protein Services

Price on request
Request a quote for more information about this service.

ic

Microbiology

Price on request
Request a quote for more information about this service.

ic

Pharmacology & Toxicology

Price on request
Request a quote for more information about this service.

ic

Formulation Services

Price on request
Request a quote for more information about this service.

ic

In vitro Bioavailability/Bioequivalence Studies

Price on request
Request a quote for more information about this service.

ic

Chromatography

Price on request
Request a quote for more information about this service.

ic

Biology

Price on request
Request a quote for more information about this service.

ic

Storage

Price on request
Request a quote for more information about this service.

ic

Sterility Testing

Price on request
Request a quote for more information about this service.

ic

Chemical Stability Testing

Price on request
Request a quote for more information about this service.

ic

Project Management

Price on request
Request a quote for more information about this service.

ic

R&D Services

Price on request
Request a quote for more information about this service.

ic

Quality Assurance

Price on request
Request a quote for more information about this service.

ic

Process and Scale-Up Chemistry

Price on request
Request a quote for more information about this service.

ic

Contract Services Directory

Price on request
Request a quote for more information about this service.

ic

Animal Models and Studies

Price on request
Request a quote for more information about this service.

ic

In vivo Drug Efficacy Testing

Price on request
Request a quote for more information about this service.

ic

Pilot-Scale Filling

Price on request
Request a quote for more information about this service.

ic

Parenteral Formulation Development

Price on request
Request a quote for more information about this service.

ic

Injectable Packaging

Price on request
Request a quote for more information about this service.

ic

Protein Manufacturing

Price on request
Request a quote for more information about this service.

ic

Peptide Manufacturing

Price on request
Request a quote for more information about this service.

ic

Product Testing Services

Price on request

Product Testing Services

Product Testing Services

Show less

ic

Physical Analysis Methods

Price on request

Physical Analysis Methods Services

Physical Analysis Methods Services

Show less

Not finding what you're looking for?

Get info on this provider's capabilities without requesting a quote.

Integrity Bio has not received any reviews.

Integrity Bio has not received any endorsements.