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Solvias AG

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Kaiseraugst, CH

About Solvias AG

Solvias is a world leader in contract research, development and manufacturing. The industries we serve include pharmaceuticals, biotech, medical devices and cosmetics. Solvias is mainly management- and employee-owned and headquartered near Basel, Switzerland. Over 400 highly-qualified employees work together as... Show more »

Solvias is a world leader in contract research, development and manufacturing. The industries we serve include pharmaceuticals, biotech, medical devices and cosmetics. Solvias is mainly management- and employee-owned and headquartered near Basel, Switzerland. Over 400 highly-qualified employees work together as a team to understand our customers’ needs.

We take pride in delivering innovative solutions that meet the highest quality standards. With our excellent infrastructure and unrivalled expertise, we develop, analyze and test a wide range of biological and chemical substances and products. Drawing on our well-established scientific experience and proven track record, we provide integrated services, products and technologies that enhance the value chain for customers worldwide.

Our service portfolio covers:

  • Analytical Services
  • Small Molecule Analysis
  • Biopharmaceutical Analysis
  • Solid-State Development – polymorphism, salts, and crystallization
  • Ligands & Catalyst Technology
  • Custom Synthesis & Manufacturing
  • Microbiology & Biological Analysis

Our product portfolio covers:

  • Chemical Hazard Monitoring
  • Ligands
  • Fiberoptic Probes and Flow Cells
  • Software development

Our laboratories operate to the highest standards and in accordance with ISO, GMP and FDA regulations.

Solvias R&D experts can rapidly develop scalable, robust and cost-effective chemical processes and optimized reaction conditions for your highly sophisticated compounds, chiral intermediates or APIs.

Our processes can be readily transferred to our kilogram-scale laboratory either as a proof of concept study, or for scale-up and delivery of material to support your pre-clinical studies. We can also enable process transfer to a custom manufacturer of your choice.

Solvias Process R&D expert services include:

Evaluation, scouting and development of new synthesis routes for your target molecule
Optimization of reaction conditions to reduce manufacturing costs, by classical methods or statistical design of experiments (DOE)
Rapid screening of reaction conditions (e.g. Hydrogenation, Carbonylation, CX-coupling etc.) using a Symyx platform
Development of reliable analytical methods for in-process control for intermediates and APIs
Scale-up of new and existing routes in glass reactors (10-30L) and fixed reactors (up to 100L capacity) to fulfil your requirements and meet your timelines
Development of robust and scalable crystallization procedures for intermediates and APIs
Synthesis of APIs for preclinical and clinical studies up to phase III
Our solutions are based on in-depth industrial experience and innovative processes. These help you to meet your Cost of Goods target and generate valuable new IP rights.

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Our Services (98)


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ICH Stability Testing

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Elemental Analysis

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Process and Scale-Up Chemistry

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Biopharmaceutical Process Development

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Polymorphism Screening

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Solvias screens substances to identify and characterize new polymorphic forms, hydrates and solvates, and to understand the relationship between the different solid phases.

We offer different study types depending on the development stage of your active ingredient. The project scope will influence the choice of a specific... Show more »

Solvias screens substances to identify and characterize new polymorphic forms, hydrates and solvates, and to understand the relationship between the different solid phases.

We offer different study types depending on the development stage of your active ingredient. The project scope will influence the choice of a specific polymorphism screening. Considerations include:

  • Stage of development (pre-clinical, clinical, approved)
  • Special regulatory status (fast track, orphan drug)
  • Desired time to market / potential of drug
  • Already available data, availability of material
  • Required confidence level, risk / benefit assessment
  • Intellectual property aspects

Our flexible study designs and process-relevant planning can be tailored to your needs through a choice of approaches:

Preliminary Study

The aim of this study is to identify the thermodynamically stable form and hydrates with a reasonably high probability while keeping the experimental effort limited. One of these forms is generally the optimal one for further development. It is therefore particularly suitable for an early stage of development.

Propensity Screen

This is a quick and economical study using our robotic high-throughput screening instrument. It is designed to obtain preliminary information with respect to the propensity of an API to form multiple crystalline forms. This program is very useful to get a first insight into complexity of the polymorphism for a given substance.

Profile Study Type

Complete profiling of the polymorphic behaviour can be achieved with this study type. The Micro-HTS study is supplemented with numerous medium-scale crystallization experiments as well as mechanical and thermal experiments with the solid, which gives the highest chance of finding all relevant polymorphic forms. All forms are thoroughly characterized and their relative stabilities evaluated. This offers the best chance for generating intellectual property, minimizing the probability of any unexpected problems with solid forms during development and commercialization. Thorough elucidation of the thermodynamic properties of the various forms also facilitates the crystallization development.

We can also offer customised screens according to your requirements.

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Solid Dosage Formulation

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As the majority of drugs are administered as solids, solid-state properties of the active ingredient significantly influence the performance of the final product.

Most substances can crystallize as different solid forms (polymorphs, hydrates, solvates, co-crystals). Furthermore, a large fraction of active ingredients are... Show more »

As the majority of drugs are administered as solids, solid-state properties of the active ingredient significantly influence the performance of the final product.

Most substances can crystallize as different solid forms (polymorphs, hydrates, solvates, co-crystals). Furthermore, a large fraction of active ingredients are weak acids or bases which offers the possibility to form salts which can again be produced in various solid forms. All these forms will behave differently, and it is of critical importance for the success of a drug to screen for the various forms, characterize them and select the “optimal” solid form.

Solvias is home to scientific leaders and experts in the field who can help you select the best available crystalline candidate. This is where the following physical and chemical properties mainly play a role:

  • Solubility (dissolution rate)
  • Stability (chemical and physical)
  • Melting point
  • Hygroscopicity
  • Processability (particle behaviour, flowability)
  • Ease of preparation
  • Polymorph landscape complexity and polymorphic transformations

In addition to its impact on chemical and physical properties, new solid forms are also relevant for intellectual property considerations – as solids with superior properties can be patent protected.

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Chemical Reference Standards

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Well-characterized reference substances are a prerequisite for the accuracy of pharmaceutical analyses. We can advise you on best practice and the elements required for your analytical certification program. Solvias provides a comprehensive service for reference substances of small molecules and biopharmaceuticals:

These... Show more »

Well-characterized reference substances are a prerequisite for the accuracy of pharmaceutical analyses. We can advise you on best practice and the elements required for your analytical certification program. Solvias provides a comprehensive service for reference substances of small molecules and biopharmaceuticals:

These include:

  • Synthesis of reference substances
  • Isolation, purification or enrichment of by-products needed as reference substances
  • Characterization of reference substances
  • Full certification to GMP requirements
  • Packaging e.g. weighed quantities in vials, including certificate of analysis
  • Appropriate storage and logistics
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Impurity Analysis

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Solvias characterizes drug substances to meet regulatory requirements for your registration dossiers. Analyses range from physico-chemical parameter evaluation and pre-formulation right up to the establishment of complete analytical test programs. We can support you on the specific characterization elements required to satisfy... Show more »

Solvias characterizes drug substances to meet regulatory requirements for your registration dossiers. Analyses range from physico-chemical parameter evaluation and pre-formulation right up to the establishment of complete analytical test programs. We can support you on the specific characterization elements required to satisfy the requirements of the regulatory authorities.

Our analytical services include:

  • Elemental composition and impurities
  • Solubility (aqueous and non-aqueous)
  • pKa
  • Partition coefficient
  • Spectroscopic characterization (MS, NMR, IR, UV)
  • Excipient and packaging compatibility
  • Particle size analysis
  • Initial stability
  • Solid-state properties
  • Impurity identification and quantification
  • Other techniques e.g. microtitration to minimise sample use
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Chemical Analysis

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Small, chemically manufactured molecules are the classic active drug substances that continue to make up the majority of pharmaceuticals on the market today. Solvias provides a comprehensive range of contract analytical services to the pharmaceutical industry for raw materials, intermediates, active pharmaceutical ingredients... Show more »

Small, chemically manufactured molecules are the classic active drug substances that continue to make up the majority of pharmaceuticals on the market today. Solvias provides a comprehensive range of contract analytical services to the pharmaceutical industry for raw materials, intermediates, active pharmaceutical ingredients (APIs) and drug products. We offer the ideal combination of leading edge technology, extensive knowledge and flexible capacity to provide GMP-compliant analytical services that meet your needs – from single orders to large development projects.

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Energy Dispersive Spectroscopy

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X-Ray Powder Diffraction

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X-ray Crystallography

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Wet Chemical Analysis

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UV-VIS Spectroscopy

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Trace Metal Analysis

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Thermogravimetric Analysis (TGA)

Thermogravimetric Analysis
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Chemical Stability Testing

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Product Stability Testing

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At Solvias, we are ideally placed to provide stability testing for all stages of drug development. Our stability storage infrastructure includes sophisticated walk-in chambers, climate cabinets and an emergency backup for power breakdown. All our processes take place on one connected site, where there is a high degree of QC... Show more »

At Solvias, we are ideally placed to provide stability testing for all stages of drug development. Our stability storage infrastructure includes sophisticated walk-in chambers, climate cabinets and an emergency backup for power breakdown. All our processes take place on one connected site, where there is a high degree of QC expertise, scientific dialogue and maximal sample preservation.

Testing we regularly perform includes:

  • Long-term stability studies according to ICH guidelines
  • Ongoing and follow-up stability studies
  • Comparability studies
  • Stress tests, forced degradation
  • Photostability testing according to ICH guidelines
  • In-use tests, freeze-thaw cycles
  • Excipient/API compatibility
  • Interaction studies with primary packaging
  • Stability protocols, reports and interim reports
  • Stability indicated method development
  • Identification of unknown/new impurities
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Cell Culture Scale-Up

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Raw Material Testing

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Quality Assurance

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Bioprocess Development and Scale-Up

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In vivo Drug Efficacy Testing

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PCR

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Photostability Studies

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Particle Analysis and Characterization

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Microscopic Analysis

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Microbiology Testing

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  • Test for sterile products (rapid sterility test, sterility test, bioburden, Mycoplasma detection)
  • Test for non-sterile products (Microbial Limit Test (MLT), challenge test)
  • Environmental testing (water analyses, mapping, microbiological identification, disinfectants)
  • Specialised studies (antibiotics, integrity testing, alternative methods)
  • Test for sterile products (rapid sterility test, sterility test, bioburden, Mycoplasma detection)
  • Test for non-sterile products (Microbial Limit Test (MLT), challenge test)
  • Environmental testing (water analyses, mapping, microbiological identification, disinfectants)
  • Specialised studies (antibiotics, integrity testing, alternative methods)
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Microbiology Quality Control

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Micro FT-IR Analysis

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Material Testing Services

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Mass Spectrometry

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Custom Manufacturing

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Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
    -... Show more »

Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
  • Polymorphism, salt and crystallization programs
  • Enantioselective catalysis
  • Analytical method development and forced degradation studies
  • API synthesis up to multi kg scale under GMP or nonGMP

Whether you are looking for complete chemical development of your drug candidate or just single sections, we can create a unique and customized package. Our strong alliances give you ready access to scale-up and manufacturing of the highest-quality APIs. This combination of resources, expertise and flexibility means we can provide you with tailored solutions that exactly match the needs of your product.

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Clinical Trials Supply Manufacturing

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Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
    -... Show more »

Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
  • Polymorphism, salt and crystallization programs
  • Enantioselective catalysis
  • Analytical method development and forced degradation studies
  • API synthesis up to multi kg scale under GMP or nonGMP

Whether you are looking for complete chemical development of your drug candidate or just single sections, we can create a unique and customized package. Our strong alliances give you ready access to scale-up and manufacturing of the highest-quality APIs. This combination of resources, expertise and flexibility means we can provide you with tailored solutions that exactly match the needs of your product.

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Pharmaceutical Manufacturing

Price on request

Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
    -... Show more »

Solvias has all the resources you need for chemical development – from pre-clinical support to supply of material for clinical trials up to Phase III.

Our proven development and manufacturing expertise includes:

  • Process research and development
  • Pre-clinical investigations (material for toxicology studies)
  • Polymorphism, salt and crystallization programs
  • Enantioselective catalysis
  • Analytical method development and forced degradation studies
  • API synthesis up to multi kg scale under GMP or nonGMP

Whether you are looking for complete chemical development of your drug candidate or just single sections, we can create a unique and customized package. Our strong alliances give you ready access to scale-up and manufacturing of the highest-quality APIs. This combination of resources, expertise and flexibility means we can provide you with tailored solutions that exactly match the needs of your product.

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Batch Release Testing

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Hit to Lead and Lead Optimization

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Regulatory Affairs Consulting

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HPLC

High Performance Liquid Chromatography
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Pharmaceutical Formulation

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Forced Degradation Studies

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Extractable and Leachable Testing

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High Throughput Screening (HTS)

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Drug Discovery

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Drug Development

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Solubility and Dissolution Testing

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Chemical Synthesis

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Solvias has all the experience, resources and expertise required to meet your custom synthesis and manufacturing needs.

Custom synthesis

  • lead synthesis up to 20 kg or more
  • synthesis of scaffolds and building blocks
  • synthesis/isolation of reference compounds

Process R&D

Solvias has all the experience, resources and expertise required to meet your custom synthesis and manufacturing needs.

Custom synthesis

  • lead synthesis up to 20 kg or more
  • synthesis of scaffolds and building blocks
  • synthesis/isolation of reference compounds

Process R&D

  • for chiral intermediates, APIs or other compounds
  • development of scalable, robust and cost-effective chemical processes
  • transfer to our kilogram-scale laboratory

Chemical development & GMP manufacturing

  • from pre-clinical support to clinical trials I, II or III

Fluorination chemistry

  • development of selective protocols for challenging fluorination steps
  • multi kg production
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Package and Container Testing

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Gas Chromatography (GC)

Gas Chromatography
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Chemical Analysis

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Central Lab Services

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Biocatalyst Development

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Bioanalytical Analysis LC/MS/MS

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Assay Development

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Analytical Method Validation

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Solvias has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development... Show more »

Solvias has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development stage to provide the most cost-effective solution.

Applications include:

  • Quality Control of APIs, starting material, intermediates, finished products
  • Stability testing
  • Substance characterization
  • Formulation development
  • Cleaning validations
  • Packaging material testing, especially for extractables and leachables
  • Health, Safety and Environment
  • Specialized applications and troubleshooting

Methods developed at Solvias can be readily applied to perform routine analyses in house or alternatively can be transferred. If required, we also offer training at your facilities

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Analytical Method Development

Price on request

Solvias has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development... Show more »

Solvias has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development stage to provide the most cost-effective solution.

Applications include:

  • Quality Control of APIs, starting material, intermediates, finished products
  • Stability testing
  • Substance characterization
  • Formulation development
  • Cleaning validations
  • Packaging material testing, especially for extractables and leachables
  • Health, Safety and Environment
  • Specialized applications and troubleshooting

Methods developed at Solvias can be readily applied to perform routine analyses in house or alternatively can be transferred. If required, we also offer training at your facilities

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Analytical Chemistry Services

Price on request

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers.

Our one-stop shop of comprehensive services includes:

  • Small molecule analysis
  • Biopharmaceutical analysis
  • Solid state development
  • Microbiological and biological analysis

We pride ourselves on... Show more »

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers.

Our one-stop shop of comprehensive services includes:

  • Small molecule analysis
  • Biopharmaceutical analysis
  • Solid state development
  • Microbiological and biological analysis

We pride ourselves on being your reliable and trusted analytical service provider – with the expertise and resources you need to navigate market complexities. Our technical expertise and performance excellence means we are truly dedicated to the highest levels of customer service.

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Accelerated Stability Testing

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DNA Services

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Clinical Laboratory Services

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Spectroscopy

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Chemical Engineering and Processing

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Engineering and Fabrication

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Thermal Analysis Services

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Structural Biology

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Regulatory Affairs Services

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Drug Discovery & Development

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Clinical Research

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Physical Analysis Methods

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Liquid Chromatography (LC)

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Cells and Tissues

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Chemistry and Materials

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Bioanalytical Assays

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Manufacturing Services

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Chiral Resolution

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Product Quality Control

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Bioanalysis

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Nucleic Acid Services

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Packaging Services

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Spectrophotometry

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Microscopy

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Lead Identification and Validation

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Product Development, Testing, and Packaging

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Microbial Fermentation and Bioprocessing

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Biochemistry & Molecular Biology

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Mammalian Cell Culture

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Project Management

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Imaging & Spectroscopy

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Strength Analysis

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Product Testing Services

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Hit Identification

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Microbiology

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Synthetic Chemistry

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Chromatography

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Pharmacology & Toxicology

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Animal Models and Studies

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Biology

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Formulation Services

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