Why PER.C6® ?
Fast access to drug substances suitable for clinical phase I and II
manufacturing; less than one year from cell line generation to final drug
substance.
Standardized, scalable and robust cGMP manufacturing process.
PER.C6® cells can be utilized with batch, fed-batch and continuous
perfusion manufacturing processes.
Superior yield – PER.C6® consistently produces superior yields of
monoclonal antibodies, up to 3.5g/L. No gene amplification required.
Human-like glycosylation – PER.C6® produces therapeutic proteins
and monoclonal antibodies carrying human-like post-translational
modifications. The significant role that post-translational modifications play
in bioactivity and half-life makes PER.C6® the production system of choice for
safe and effective human therapeutic development.
Safe – PER.C6® has been extensively tested in independent laboratories
for human and animal viruses, including prions. To date, PER.C6® has met or
exceeded both US and EU regulatory requirements for cell line safety. Unlike
CHO and hybridomas, the origin and development of PER.C6® as a
biopharmaceutical production platform are known and fully documented.
Scalable, serum-free culture conditions – PER.C6® grows well in
suspension culture systems in commercially available media that is free of
human- and/or animal-derived proteins.
Compatible with existing cell culture technologies – PER.C6® is
compatible with many cell culture technologies on the market, enabling robust
growth at all scales, from roller bottles to large-scale bioreactors.
High transfectability – PER.C6® cells transfect and adapt to selection
conditions easily, allowing for rapid screening of product leads.
Highly characterized and fully documented – PER.C6® was generated
according to GLP guidelines. PER.C6® is considered the best characterized and
documented cell line to date. An extensive Biologics Master File (BMF) at the
FDA continues to expand by contributions from all licensees, resulting in
simplification and acceleration of the IND filing and approval process.
Regulatory backing – PER.C6® is currently used as the production
platform for a substantial number of clinical trials in gene therapy,
vaccines, monoclonal antibodies and recombinant proteins.
Industry endorsed – PER.C6® has been licensed to many of the major
biotech and pharmaceutical companies, including many high-profile programs.
