The two Asian biopharma companies could not be named by SAFC – the contract pharma and bio manufacturing arm of Sigma-Aldrich – but Dr. Kevin Kayser of SAFC told Outsourcing-Pharma.com that both firms were “pursuing biosimilar strategies” in the licensing of the mammalian cell line platform.
According to Kayser - who serves as Director of the platform for SAFC - there is “increasing competition to be first to market with biosimilars,” in the region and “companies are looking to make themselves more competitive.”
Furthermore he said “most companies in this region don't have resources to do extensive cell line development, so they are really looking for a system that they can use off the shelf, which is what they can do with the CHOZN Platform.”
The CHOZN mammalian cell line tech - designed to maximize the production of monoclonal antibodies and other r-proteins – was launched in 2012 and, according to Kayser, has become accepted “from both innovator and biosimilar manufacturers worldwide.”
SAFC has over 20 customers using the CHOZN platform large global biopharma companies in US and Europe, he said, as they look for “technologies that can help reduce the time it takes to bring a drug to market without sacrificing drug quality.”
He also added that while large pharma systems, such as Pfizer’s CS cell line, can save up to eight weeks of development time, SAFC matches this by having “an off the shelf system with streamlined protocols and procedures.”
“Clone development timelines can vary significantly based on what companies consider the endpoint. Timelines that suggest 8-week clone development timelines are misleading especially since stability trials alone today take 8 weeks to conduct.”
The CHOZN publishes a 14-week cell line development timeline to choose the lead manufacturing clone.
Recently Fujifilm Diosynth added a mammalian cell banking facility to its UK site and told this publication that “the mammalian side of things seems to be growing.”