Novel approach to purification and viral inactivation of new class of monoclonal antibodies

To ensure the safety of biopharmaceuticals derived from mammalian cell culture, it is critical to demonstrate that the manufacturing process is capable of clearing or inactivating potential viral contaminants and other process/product related impurities. Compared to low pH viral inactivation treatment, the detergent mediated viral inactivation (DVI) technique can provide improved product stability for monoclonal and bi-specific antibodies. Moreover, the DVI technique fit well to continuous manufacturing strategy and single-use technology.

In this presentation, we will discuss the use of affinity chromatography resin in conjunction with a novel viral inactivation agent that provides enhanced viral clearance during the purification of monoclonal antibodies. This biodegradable detergent showed benefit of less amount of detergent for viral inactivation while in compliance with regulation. The novel Protein A resin increased the impurity reduction value further while clearing detergent from the product without impacting protein quality. When used in conjunction, PROchievA™ and this novel viral inactivation solution provide a robust manufacturing process for the downstream purification of mAbs while subsequently mitigating the risks of viral contamination.

This presentation was given during BPI Boston, September 29, 2022.