Gallus BioPharmaceuticals and Omni Bio Pharmaceutical have finalized a multi-stage manufacturing agreement for cell line optimization, analytical development and scale-up for Omni Bio’s leading AAT Fc fusion protein. The goal is to provide cGMP product to support toxicology studies and early clinical trials.
Omni Bio has selected the CHOZNGS Cell line from SAFC as the expression system. SAFC will perform the cell line development and safety testing services, and Gallus will provide overall management of the process development and manufacturing services program.
“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 R. Bamforth, Gallus’ president and chief executive officer. “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.”
“We are also 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” commented Dr. Bruce Schneider, chief executive officer, Omni Bio. “We look forward to working with the Gallus technical team to advance our recombinant AAT molecule into the clinic as efficiently and effectively as possible.”