Services for Characterization of New Biological Entities

Sartorius Stedim BioOutsource, a subsidiary of Sartorius Stedim Biotech—offers NBE Product Characterization—services for the characterization of new biological entities (NBEs). BioOutsource provides a comprehensive range of testing for innovator molecules available either as off-the-shelf assays or custom assay development for more complex proteins. Tests include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses, enabling users to benefit from a fully integrated package. These testing services are fully customizable for clients to ensure their innovator drugs are tested based on regulatory requirements by expert scientists. Data packages that confirm the safety, purity, and potency required by regulatory authorities will facilitate the submissions process for approval by the European Medicines Agency (EMA) and the U.S. FDA.

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