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news.Gallus BioPharmaceuticals, a premier pure-play biologics contract development and manufacturing organization (CMO), and Omni Bio Pharmaceutical, a biopharmaceutical company focused on the commercialization of alternative uses of alpha-1 antitrypsin (AAT) for the treatment of a variety of indications and the development of next-generation recombinant forms of AAT, jointly announced finalization of a multi-stage manufacturing services agreement.
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The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio’s leading AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule.
Under the agreement, Omni Bio has selected the commercially available CHOZN GS Cell line as the expression system. 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 president and CEO Mark Bamforth said the company is delighted to partner with Omni Bio in the cell line optimization, process development and clinical supply of their AAT Fc protein.
"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," Bamforth said.
"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, CEO, 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."
AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema.
Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis.
AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), refractory gout, myocardial infarction and inflammatory bowel disease.