An antibody cocktail, produced by CHO cells in a fed-batch process, was rapidly developed to combat the COVID-19 pandemic. To ensure the product was not contaminated with endogenous or adventitious viruses in cell culture, the purification process was designed to have multiple, orthogonal, and robust viral clearance steps including virus inactivation, virus filtration and anion exchange chromatography. To support unprecedented tight timelines, the purification process was evaluated for viral clearance capacity based on historical in-house data of similar products and published scientific knowledge. This evaluation, also known as a modular viral clearance claim (as suggested by 1997 FDA Point to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use), led to an estimated ~16 log10 (1016) of cumulative viral clearance capacity from three steps. Regulatory agencies in US and Europe accepted this approach as adequate viral clearance assurance for drug product to be evaluated in clinical trials. Subsequently, product-specific experimental viral clearance studies were performed. The project-specific data confirmed and significantly exceeded the virus clearance estimates by 102.7 determined by the modular claim. The talk will speak to the holistic set of considerations and lessons learned that render this approach a feasible option for regulatory submissions in case of the need for accelerated development of similar products in the future.

Ensuring viral safety for a Covid-19 antibody cocktail

ACS Fall 2021

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