Sartorius Stedim Biotech has launched a full range of chemistry testing services via its subsidiary - Sartorius Stedim BioOutsource.
The service platform methods have been developed to ensure rapid sample analysis and reporting for mAbs and biosimilars. Services comply with ICH Q6B scientific guidelines for pharmaceuticals for human use, and include methods to characterise protein structure, carbohydrate profile, post-translational modifications and impurities utilising UHPLC and LC/MS instruments.
In order to provide the services, SSB has expanded laboratory space by 340 m2 at its facility in Glasgow, UK, and has appointed new scientists with extensive chemistry testing experience.
The chemistry testing service complements SSB’s existing range of off-the-shelf biological assays for biosimilar products. Structural and functional analyses can be conducted in parallel in order to deliver a comprehensive data package for regulatory submissions.
Dr. Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource, said: “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 characterisation data required. Expanding our portfolio with these new services was a logical step following the successful launch of our Released N-Glycan assay in 2016.”