Biologics Testing Services
Comprehensive analytical testing services from discovery to commercial production
Producing biologics from mammalian cells and viruses carries an inherent risk of microbial and viral contamination. Regulatory agencies such as the EMA, MHRA, and FDA require rigorous biologics testing tailored to the cell or viral system and the product’s intended use.
Sartorius offers end-to-end biologics testing solutions from discovery through commercial release. Our global cGMP-compliant facilities, approved by the FDA and MHRA, support testing for viral vector gene therapies, cell therapies, viral vaccines, novel biologics, and biosimilars.
By outsourcing biologics testing to Sartorius, you can accelerate analytical development and lot release with immediate access to specialized, ready-to-use or custom assays, platform methods, and advanced analytical equipment — effectively extending your quality control capabilities.
Biologics testing services
Why partner with Sartorius for biologics testing?
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 current Good Manufacturing Practice (cGMP) guidelines. We are fully approved and routinely audited by major regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA), 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 adeno-associated virus (AAV) testing services tailored to 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 (NBEs 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.
