This range of chemistry testing services complies with the ICH Q6B scientific guidelines for pharmaceuticals for human use, and includes methods to characterize protein structure, carbohydrate profile, post-translational modifications and impurities utilizing UHPLC and LC/MS instruments. To provide these services, SSB has expanded laboratory space by 340 square-meters at its facility in Glasgow, UK, and has appointed new scientists.
This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products, providing a complete solution from one contract partner. This allows structural and functional analyses to be conducted in parallel to deliver a comprehensive data package for regulatory submissions. As a result, the full-range of services enables SSB to even better support its customers in their drive to bring innovative biologic drugs to market.
“Rapid data-driven decisions at critical stages are crucial for the successful development of biosimilars. Our chemistry testing services enable biosimilar manufacturers to benefit from side-by-side biological and physicochemical analyses to gain the in-depth characterization data required,” said Daniel Galbraith, chief scientific officer, Sartorius Stedim BioOutsource. “Expanding our portfolio with these new services was a logical step following the successful launch of our Released N-Glycan assay in 2016.”