Gallus BioPharmaceuticals, LLC, a biologics contract development and manufacturing organization, and the biopharmaceutical company Omni Bio Pharmaceutical, Inc. have formed a multistage manufacturing services agreement. Omni Bio is focused on the commercialization of alternative uses of alpha-1 antitrypsin (AAT) and recombinant forms of AAT for various indications.

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. Under the agreement, Omni Bio has selected the commercially available CHOZN GS Cell line commercially available from Sigma-Aldrich's custom manufacturing and services business unit 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.

Source: Gallus BioPharmaceuticals