Date: 2012-11-13
Type of information: Development agreement
Compound: recombinant human alpha-1 antitrypsin (hAAT) - CAP® cell line - GPEx® technology
Company: Catalent Pharma Solutions (USA) Cevec Pharmaceuticals (Germany)
Therapeutic area:
Type agreement: development
commercialisation
promotion
Action mechanism:
Disease:
Details: Catalent Pharma Solutions has reached a commercial cell line sales agreement with CEVEC Pharmaceuticals for recombinant human alpha-1 antitrypsin (hAAT). The companies have also signed a joint development and marketing agreement that combines CEVEC’s CAP® cell line, a high performance protein expression platform originally derived from primary human amniocytes and Catalent‘s GPEx® technology, a powerful gene-insertion method providing single-copy gene integration at multiple genomic locations in dividing cells. This agreement will allow the co-promotion of the combined technologies to biotechnology companies needing cell line development and manufacturing of various proteins.
The announcements follow a successful five month study which achieved a new milestone in the field of complex protein production, having demonstrated a record yield for a non-antibody protein produced in a human expression system. Catalent, and CEVEC achieved a manufacturing yield of over 3 grams per liter for a secreted, highly glycosylated non-antibody protein, using the challenging hAAT molecule which harbors 3N-glycosylation sites, through a combination of two highly innovative proprietary technologies. The program began with the development of a GPEx based stable pool in CAP cells at Catalent, followed by initial process development at CEVEC.
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