Sartorius Stedim Biotech launched a full range of chemistry testing services. Offered by its subsidiary Sartorius Stedim Bio Outsource, they characterize the physicochemical properties and structural attributes of therapeutic monoclonal antibodies (mAbs).
Glasgow/Ireland — According to the company, the service platform methods have been developed to ensure rapid sample analysis and reporting for mAbs and biosimilars. This comprehensive 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, the supplier said.
To provide these services, Sartorius has expanded laboratory space by 340 m2 at its facility in Glasgow, UK, and has appointed new scientists with extensive chemistry testing experience. This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products. The supplier intends to offer structural and functional analyses to be conducted in parallel to deliver a comprehensive data package for regulatory submissions.
“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,” explained Dr. Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim Bio Outsource. “Expanding our portfolio with these new services was a logical step following the successful launch of our Released N-Glycan assay in 2016,” he added.