Catalent Pharma Solutions has announced that it had 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.
Leading global drug development and delivery solution provider Catalent, and CEVEC, the developer of a novel, market-leading human protein expression system derived from amniocytes, 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.
“Enabling biotech companies to get clone candidates to clinic more quickly and efficiently is at the core of Catalent’s biologics business philosophy,” commented Kent Payne, Vice President and General Manager, of Catalent’s Biologics business.
Payne continued, “Having developed the hAAT molecule using our combined technologies, we have now reached a commercial agreement with CEVEC on the cell line and look forward to further drawing on this combination in the development of additional recombinant proteins and antibodies.”
“We are very excited to have proven the potential for generating high expressing human cell lines in a much shorter timeframe than traditional methods,” added Wolfgang Kintzel, CEO of CEVEC.
Kintzel continued, “As the yield of 3 g/L was achieved already at the stable pool stage, a further increase in productivity is expected by the ongoing generation of the clonal cell line. The high yield attained for a difficult to express and therapeutically relevant protein, such as hAAT, represents an enabling milestone for large scale manufacturing of complex proteins in human cells.”