ZAC-3 Developing and manufacturing a low cost mAb against V. cholerae

Project Aims - Engineer and evaluate three variants of ZAC-3 utilizing LS and YTE Fc-modifications. - Evaluate humanized ZAC-3 IgG derivatives for functional activities, including V. cholerae agglutination, V. cholerae motility arrest, complement-mediated vibriocidal activity, and reduction in V. cholerae intestinal colonization. - Engineer highly productive CHO cell-line expressing +2 g/L to 8 g/L. - Develop production process increasing productivity 20% to 50% over cell-line performance. - Develop downstream process achieving >70% yield; and exceeding viral-clearance requirements. - Create viable subcutaneous injection delivery method. - Manufacture +20 grams of MAb for pre-clinical IND-enabling studies. - Clinical manufacturing process achieves <$20 per gram. Long-term Program Aspirations - An approved effective prophylactic MAb against cholera where none currently exists. - Biomanufacturing resulting in COGS below $10 per gram at commercial scale. - Formulation limiting, or eliminating, reliance on complex cold chain storage, facilitating deployment to outbreak areas. - Sharing IP technology developed under this program with others working for equitable public health. - Creating a new pathway that can be replicated with other recombinant proteins for diseases affecting LMICs, displaced persons, and those afflicted by diseases of poverty. Our goal is to create a new pathway for ourselves and other organizations to provide low cost biologic drugs to those unable to access such medicines.