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.
Focus on Value-Added Activities
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.
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.
Dedicated Client Management
Our dedicated client managers work in partnership with your project management team, guiding you through each step in the process.
Learn More About Biologics Testing
Frequently Asked Questions
Biologics testing is a critical step in biopharmaceutical manufacturing that ensures the safety, purity, and efficacy of protein-based biologics, biosimilars, and viral vaccines. Because biologics are produced from living organisms (like mammalian cell lines), there is an inherent risk of microbial and viral contamination. Testing is required by regulatory bodies to guarantee the product is safe for human use before it reaches the market.
Our global testing facilities operate under stringent cGMP (Current Good Manufacturing Practice) guidelines. We are fully approved and routinely audited by major regulatory agencies, including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and MHRA (Medicines and Healthcare products Regulatory Agency), ensuring your testing data supports global regulatory submissions.
Cell line characterization is essential to confirm the identity, genetic stability, and purity of the mammalian cell banks used to produce your biologic. It proves that your cell line is free from adventitious agents (like bacteria, fungi, mycoplasma, and viruses) and guarantees reproducible manufacturing across the lifecycle of your drug.
Our lot release testing provides a comprehensive panel of analytical and biosafety assays required to commercialize your biologic. This includes testing for identity, potency, purity, and safety (such as endotoxin, mycoplasma, and sterility testing) to ensure every manufactured batch meets strict pre-defined quality specifications before patient administration.
Yes. We offer specialized AAV (Adeno-Associated Virus) testing services tailored for the unique challenges of viral vector gene therapies. Our experts provide purpose-built instrumentation and custom assays to characterize your viral vectors, ensuring their safety and efficacy for gene delivery.
Outsourcing your quality control (QC) testing to Sartorius allows you to bypass the time and expense of setting up your own compliant testing facilities. By leveraging our pre-validated cGMP assays, specialized analytical equipment, and regulatory experts, you can instantly expand your testing capacity and focus your internal resources on core drug and process development.
Testing is required in all modalities and product types. We have regularly worked with: mAbs (NBE and biosimilars), fusion proteins, bi-specifics, viral seed stock, viral vaccines, viral vectors for cell and gene therapies, cell therapies, and more.
Testing is performed in Glasgow, UK. Mammalian Suspension Cell Bank Manufacturing is performed near Glasgow, UK. Mammalian Adherent Cell Bank Manufacturing is performed in Lyon, France.
