A Comprehensive Portfolio of Test Methods to Ensure Biopharmaceutical Products Are Free of Contaminants
Biological products derived from mammalian cell lines pose an inherent risk for the introduction of microbial or viral contaminants. In addition, the manufacturing process or product itself may introduce impurities that must be characterized.
Biopharmaceutical manufacturers must carry out stringent testing to ensure all biologic materials, across the development process, are safe, free of contaminants and characterized. This includes all starting materials, such as cell banks and viral seed stocks, as well as products advancing through clinical and commercialization phases. Ready-to-use Quality Control Plans support the full range of biosafety testing at every step, shortening the time it takes to get results.
The exact approach to sampling and testing is specific to a product and the manufacturing process, but it typically includes:
- Unpurified Bulk Harvest — Tested primarily for biosafety, demonstrating freedom from microbial and viral contaminants
- Drug Substance — Tested primarily for characterization purposes to show product and process purity profile
- Drug Product — Tested for biosafety, quantity and purity, and product quality
Sartorius provides comprehensive biosafety testing packages compliant with global pharmacopoeia standards, carried out in facilities accredited by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK.
Ensuring that biosafety testing and characterization assays are scientifically sound and meet cGMP regulations is a complex process that requires multifaceted expertise, and often results in a significant investment of time and resources. Outsourcing biosafety testing, characterization and product specific assay development to Sartorius removes these barriers and allows you to focus on drug development and product manufacturing.
Our scientific experts and regulatory quality professionals work closely with your product teams to oversee testing across the entire drug product journey, from initial drug discovery to commercial manufacturing.
Reaching critical development milestones on schedule, such as Phase I clinical trials or approval to launch, is of utmost importance for biomanufacturers. Sartorius provides ready-to-use QC testing plans and pre-validated cGMP tests so development teams can readily access the specialized testing that’s needed. Testing plans can be easily customized to meet specific product parameters, with rapid development of product-specific assays. They can also be accelerated by taking advantage of rapid assays based on polymerase chain reaction (PCR) or enzyme-linked immunosorbent assay (ELISA).
We offer testing plans for:
- Products Derived from Chinese Hamster Ovary (CHO) Cell Lines
- Viral Vaccine and Viral Vector Seed Stocks
- Viral Vector and Viral Vaccine Products
Navigating the regulatory pathway to a first batch lot release is complex. It takes a focused team of experts to oversee testing and characterization activities. Sartorius provides a dedicated client manager to coordinate biosafety testing and to liaise with commercial development teams. Our team will guide you through the process and ensure success.