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GMP Compliance

GMP Compliance

To keep up to date with the GMP requirements, Protagen Protein Services GmbH is a member of EAPB (European Association of Pharma Biotechnology). For us, the scientific information and opinion exchange and the promotion of education, as well as the contact for national and international organizations is important.

Both sites of Protagen Protein Services GmbH in Dortmund and Heilbronn are regularly inspected by the local authorities in Arnsberg and Tübingen, respectively. Please find our current GMP certificates in the download area.

SERVICES

Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:

  • Developability
  • Clone Selection & Process Development
  • Extendend Characterization & Comparability
  • Stability & Release

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