Biologics Testing

A Comprehensive Biologics Testing Service Supports Drug Developers and Commercial Biologics Manufacturers From Discovery Through Commercial Manufacturing

When producing biologic products from mammalian cell lines and viruses, there is an inherent risk of introducing microbial- and viral-based contaminants. Regulatory bodies such as the European Medicines Agency (EMA), Medicine and Healthcare Products Regulatory Agency (MHRA) and Food & Drug Administration (FDA) ensure the safety and test of new protein-based biologics, biosimilars, viral vector gene therapy and viral vaccines. These guidelines are determined by the nature of the cell line or virus and the intended use of the product – and compliance is demonstrated through biologics testing.

Sartorius provides comprehensive biologics testing solutions for all stages of drug development, from discovery to commercial release.

Our global cGMP-compliant testing facilities are FDA- and MHRA-approved for biologics testing of viral vector gene therapies, cell therapies, viral vaccines, new biologics and biosimilars.

Outsourcing biologics testing to Sartorius expedites analytical development and lot release timelines with immediate access to highly specialized ready-to-use or custom assays, platform methods and complex analytical equipment – ultimately expanding your quality control workbench.

Outsourcing Biologics Testing Allows You to Focus on Value-Added Activities
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Speed & Capacity

Skip expensive and time-consuming setup of regulatory compliant testing facilities by accessing ready-to-use QC testing plans and pre-validated cGMP assays.  

Extend your analytics development capacity by using our rapid, product-specific assay development service, freeing your team to focus on drug and process development goals. 

Commercial-scale producers can leverage their internal analytics capacity by outsourcing biologics testing to a reliable partner. 

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Expertise

The pathway from R&D analytics to cGMP compliant release assays is complex and multifaceted.  

As experts in the biologics testing of protein- and viral-based products, our extensive knowledge of and experience with complex protein molecules and viruses allows us to develop specialized, high-quality analytics and product release assays.

Our regulatory quality professionals guide customers from drug discovery to commercial product release, with biologics testing plans tailored for your specific development phase.

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Dedicated Client Management

Our dedicated client managers work in partnership with your project management team, guiding you through each step in the process.

Focus Topics

Cell Line Characterization

A broad range of services to characterize your mammalian cell banks in accordance with regulatory guidelines.

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Product Characterization

Purpose-built instrumentation, ready-to-use and custom assays meet characterization challenges of increasingly complex biologics.

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Biologics Lot Release Testing

Ready your biologic for market launch with a complete lot release testing solution.

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Related Assets

Brochure: Biosafety Testing for Biologics and Viral Vaccines

PDF | 406.2 KB

Brochure: New Biological Entity - Product Characterization Services

PDF | 2.0 MB

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