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.
Method Development and Qualification to Validation
Method development to validation services provide comprehensive analytical support, ranging from early method development and qualification to GMP-compliant validation. Established platform assays and product-specific techniques help ensure reliable, regulatory-ready data from preclinical stages through to commercialization.
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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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Services by Modalities
Charles River's provides GMP‑compliant testing modality‑specific services for complex biologics, including viral vectors, cell therapies, vaccines, and mAbs. End-to-end analytical, safety, and release testing supports quality, regulatory alignment, and faster market progression.
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Introducing Apollo™ for Biologics
Apollo™ 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), analytical services, 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.
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.
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.
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