Catalent Pharma Solutions and Cevec Pharmaceuticals have entered a commercial cell line sales agreement for recombinant human alpha-1 antitrypsin (hAAT). The companies have also signed a joint development and marketing agreement combining their respective technologies, Cevec’s CAP cell line, a high performance protein expression platform and Catalent’s GPEx technology, a gene-insertion method providing single-copy gene integration at multiple genomic locations in dividing cells.
Cevec, a developer of a human protein expression system derived from amniocytes, achieved a manufacturing yield of more than three grams per liter using the hAAT molecule through a combination of the two 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,” said Kent Payne, vice president and general manager, of Catalent’s Biologics business. “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,” said Wolfgang Kintzel, chief executive officer of Cevec. “As the yield of 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.”