PER.C6 Manufacturing Platform

PER.C6 – The Manufacturing Platform. An alliance between Crucell NV and DSM Biologics.

The PER.C6® manufacturing platform is ideally suited for the development of clinical and large-scale manufacturing of a wide range of biopharmaceuticals.

DSM and Crucell N.V. of Holland collaborated in establishing PER.C6 as the novel industry platform for the production of proteins, and have jointly signed PER.C6 license agreements for proteins with a multitude of companies worldwide.

What is offered?

• We bring your molecule to the clinic fast
• We give you human-like products
• We provide them with low cost-of-goods

What are the leading qualities of the PER.C6 manufacturing platform?

• Cell line generation
• Process development
• Fed-Batch, Continuous Perfusion & DSP
• Sterile Fill and Finish
• Optimized for Monoclonal Antibody & Protein Production
• High yields
• Human Post-translational Modifications
• Easily Scalable
• Serum-Free Culture Conditions
• Proprietary Patent Position
• Extensive Biologics Master File

The specifics of PER.C6:

• Optimized for Antibody Manufacturing
  • Superior yield – PER.C6™ consistently produces superior yields of monoclonal antibodies in a stable manner, with no gene amplification required.
  • Human glycosylation – PER.C6™ produces therapeutic proteins and monoclonal antibodies carrying human post-translational modifications. The significant role that post-translational modifications play in bioactivity and half-life makes PER.C6™ the production system of choice.
  • Safe human cell line – PER.C6™ has been extensively safety tested for human and animal viruses; all tests turned out negative. Unlike cho and hybridomas, its origin and transformation event are known.
  • It does not contain any viruses or prions. It has passed all safety tests, including retrovirus assays.
  • Scalable, serum-free culture conditions – PER.C6™ grows well in suspension culture systems using media that is free of any human- or animal-derived proteins. The flexible culture conditions enable robust growth at all scales, from roller bottles to very large-scale bioreactors.
  • High transfectability – PER.C6™ cells are well-suited for both transient and stable transfection work, allowing for rapid screening of product leads.

• Industry Endorsed, Regulatory Backing
  • Highly characterized and fully documented – PER.C6™ was generated according to GLP guidelines. Crucell believes that after only six years of development, PER.C6™ is the best characterized and documented cell line to date. Its extensive Biologics Master File (BMF) at the FDA continues to expand by contributions from licensees such as Merck, resulting in simplification and acceleration of the IND filing and approval process.
  • Regulatory backing - PER.C6™ is currently used in six Phase I/II trials for gene therapy. The FDA has also accepted PER.C6™ produced HIV vaccine in Merck's Phase I/II trials with healthy volunteers and immuno-compromized individuals.
  • Industry endorsed – PER.C6™ is licensed by many of the major biotech and pharmaceutical companies, including Merck & Co, Glaxo SmithKline, Novartis, Aventis, Schering AG, Pfizer/Warner Lambert, Genzyme, Oxford Biomedica, Ark Therapeutics, Transgene, DirectGene, Cell Genesys, Bioheart, and ML Laboratories.
  • Proprietary patent position – Crucell owns the full rights to the PER.C6™ cell line.