Sartorius Stedim BioOutsource Ltd. (part of Sartorius Stedim Biotech Group) is one of the world’s leading providers of contract testing & research services to the biopharmaceutical and biotechnology industries. Offering an extensive range of services to support the testing of biologic drugs and vaccines throughout development and manufacture. In particular, BioOutsource specializes in the characterization and comparability of biosimilar monoclonal antibodies.
Our scientists possess unrivaled scientific and regulatory expertize to help solve the complex challenges encountered during the development of biosimilars, biologics, and vaccines. At BioOutsource, we assess the quality and safety of biologics, advancing drug candidates through each phase of the drug development pathway by:
✔ Reduced speed to market – The most comprehensive range of off-the-shelf assays for biosimilar development
✔ Innovative technical expertise – Industry leading technical expertize in bioanalytical and biosafety testing services. As well as in-house R&D department constantly adding to our testing services
✔ Quality assurance – Quality driven results and regulatory insight for data generation
✔ Dedicated client support – Single point of contact for clients with regular updates, support, and advice

Specialties: Biosimilar Testing, Bioanalytical Testing, Biosafety Testing, Genetic Analysis, Cell Bank Manufacturing, Cell Line Development, CHO Cell Line, Protein Characterization, Monoclonal Antibodies, Contract Testing, Contract Research , Product Characterization, New Biological Entities (NBE), Biologics Testing, Gene Therapy, and mAbs Testing