The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio’s AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule.
“We are quite pleased to be entering into this relationship with Gallus, a very experienced CMO with an excellent track record of manufacturing both early-stage and commercial-stage biopharmaceutical products,” said Bruce Schneider, CEO, Omni Bio.
Under the agreement, Omni Bio has selected the commercially available CHOZN GS cell line, which is commercially available from SAFC. In addition, SAFC will perform the cell line development and safety testing services, in conjunction with Gallus’ overall management of the process development and manufacturing services program for Omni Bio.
“Gallus is delighted to partner with Omni Bio in the cell line optimization, process development and clinical supply of their AAT Fc protein,” said Mark Bamforth, Gallus’ President & CEO. “We are confident that our deep process development expertise and direct experience with Fc fusion molecules will result in high quality material effectively delivered to meet Omni Bio’s goals.”
In related news, Gallus has chosen to use TAP Biosystem’s ambr15 micro bioreactor system at its St Louis, Missouri facility, in order to determine which CHO cell lines are stable and produce the highest titre mAbs.
“Our clients want high yielding, pure biotherapeutic antibodies that they can take into clinical trials as quickly as possible,” said Matt Caple, Scientific Director of Cell Culture Development at Gallus. “However, they often come to us without any process development history for their mAb clones and we have to ensure we build them a robust process.
“We used to do this with multiple shake flask and benchtop scale bioreactor runs, however, we knew we couldn’t continue to work at this labour-intensive scale. So we assessed a number of bioreactor models and concluded that the ambr15 system was the right option for us.”