Biologics Testing Solutions

Budget, capacity, and strict regulatory requirements are just some of the hurdles that can prevent the next big breakthrough from commercialization. Less than 1% of all drug candidates entering clinical trials reach the market, which means you need a partner with a proven track record of success.

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scientist working in biologic drug development testing lab

Explore our Biologics Testing Solutions

With over 40,000 tests run annually at our global biologics testing facilities and 200+ products supported; our team can provide comprehensive testing services for a wide range of modalities. These include monoclonal antibodies/recombinant proteins, viral vectors, vaccines, and cell therapies. Count on us to ensure your biologic is safe, effective, and able to pass regulatory scrutiny.

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Biologics Analytical Services

Get accurate, regulatory-compliant data with comprehensive, flexible, and phase-appropriate analytical testing services.
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AAV Testing

Our extensive, in-house AAV testing experience with rigorous characterization and biosafety testing will help ensure that your gene therapy is safe, effective, and regulatory-compliant from preclinical stages to commercialization.
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Introducing ApolloTM for Biologics

ApolloTM provides users with a centralized platform to submit sample submission forms, track samples, and exchange documents all in one place, ensuring accuracy and saving time.
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Global Biologics Testing Facilities

Pennsylvania, USA
GMP-compliant facilities in Malvern and Wayne, PA, USA, support the development of large molecule, vaccine, medical device, and gene and cell therapy products. Services include cell/viral banking, cell line characterization, biosafety testing (e.g., mycoplasma, sterility, viral safety), impurity testing, stability studies, and lot release testing.

Massachusetts, USA
The GMP-compliant in vivo biosafety laboratory located in Wilmington, MA, USA, can assist in meeting your in vivo adventitious agent testing requirements for cell line characterization or vaccine production. GMP in vivo potency testing assays and general safety tests for product release to market are also available.

Massachusetts, USA
Our Analytical Center of Excellence in Shrewsbury, MA supports method development, validation, and execution for the characterization and development of protein, glycoprotein, and peptide therapeutics.

Germany
Erkrath, Germany, offers comprehensive GMP-compliant services including cell line characterization, lot release and stability testing, biosafety testing, and impurity testing. Our facility in Cologne, Germany, offers viral clearance studies for biopharmaceuticals and medical devices. Procedures in Cologne are harmonized with the Pennsylvania site, allowing for seamless method transfer if necessary

Ireland
Ballina, Ireland, provides GMP in vivo potency bioassays, vaccine efficacy studies, challenge studies, anti-infective product discovery studies, sterility, microbiology, and pyrogen/MAT testing. Lot release studies for European, US, and international markets including viral safety, mycoplasma, and analytical testing are also available.

France
The Châtillon, France facility is designed for pharmacopoeial quality control testing and antisera production. This facility serves the pharmaceutical, veterinary, chemical, and biotechnology industries while adhering to good manufacturing practice (GMP) guidelines.

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Characterization and Release Testing for AAV Therapies
Industry experts talk about the pros and cons of different analytical methods being used in the industry for phase-appropriate empty/partial/full capsid characterization and share case studies demonstrating the importance of analytical reference material for product-specific method development and validation.
Watch the webinar