The downstream purification process of any biologic has several objectives: purity, yield, and safety for humans or animals. A critical component of safety assurance is reducing virus to levels that meet stringent regulatory requirements. Virus reduction can be achieved through multiple complementary approaches and most processes rely on a combination of technologies that are designed primarily to achieve purification targets, but may also offer opportunities for virus reduction. The purpose of this project was to establish capabilities for producing a monoclonal antibody feed enabling the development of new filtration and chromatography products. The purified antibody should have industry-representative titer, yield and purity, achieved using the EshmunoÂ® chromatography resin platform in combination with ViresolveÂ® Pro filtration devices as seen in Figure 1.
Each unit operation was optimized to maximize step purity and yield. Following optimization, virus clearance was assessed using two viruses: Minute Virus of Mice (MVM), and Xenotropic Murine Leukemia Virus (X-MuLV), Table 1.