Milestone Bioprocess Technology
Germany: Testing for Innovator Molecules Sartorius Stedim Biotech Launches Service for Characterization of New Biological Entities
Sartorius Stedim Biotech (SSB) announced the launch of services for new biological entities, called NBE Product Characterization. The company provides a comprehensive range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins.
Goettingen/Germany; Glasgow/UK — These services are offered by its subsidiary, Sartorius Stedim Bio Outsource based in Glasgow, UK, and in Cambridge, Massachusetts, USA. The tests offered by the company include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses, enabling customers to benefit from a fully integrated package. These testing services are fully customizable for clients to ensure their innovator drugs are tested based on the right regulatory requirements by expert scientists, the supplier announced. Robust data packages proving the safety, purity and potency as required by the regulatory authorities smooth the submissions process for approval by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
As a result of these fully customizable methods and data packages available for monoclonal antibody characterization that complement Bio Outsource’s and Sartorius Stedim Cellca’s existing innovative offer for biologics, pharmaceutical companies could work with one contract partner from cell line development to qualification and validation of analytical and biological product characterization assays. A panel of assays suitable for mAb characterization is to allow drug developers to fast-track complex bioassay development using the supplier's platform methods.