The foundation for approval of novel biological entities and biosimilar drugs is built on a robust analytical data package that proves the safety, purity and potency of the product. The BioOutsource analytical testing package combines physicochemical and biological analysis for in-depth characterization and comparability studies from a single contract partner. Our service offering uses platform methods, off-the-shelf assays and custom developed bioassays to enable rapid data-driven decisions during drug development and is available from pre-clinical through to clinical phases and lot release.
The demand for biosimilars is increasing as the patent cliff for many blockbuster biologics approaches. Biosimilars require comprehensive analytical characterization to demonstrate similarity to the innovator product. This can be a time-consuming and complex process requiring a range of analytical characterization methods throughout development and production.
The expert scientists at BioOutsource and Cellca have extensive experience in biosimilar analysis and testing from working with biopharmaceutical companies across the globe. We provide you with an integrated service to support your biosimilar development starting with innovator sourcing:
Characterize the structure and physicochemical properties of monoclonal antibodies during drug development with a comprehensive range of methods to characterize protein structure, carbohydrate profile, post-translational modifications and impurities. Our state-of-the-art techniques follow ICH Q6B regulatory guidelines to enable an efficient, streamlined development process.
Characterize the binding and functional activity of your biologic molecule with a range of cell-based assays, binding and potency assays. Advance the development of your biosimilar with our comprehensive range of assays, available off-the-shelf for over 12 biosimilar target molecules.
Register below for more information about how Sartorius testing services can accelerate the development of your biologics.