In connected continuous antibody manufacturing, the downstream capture system can be considered part of the upstream process. Single-use components and assemblies help to extend the sterile barrier of the bioreactor, but columns and resin remain a challenge. While single-use products such as gamma-irradiated columns are available, they are costly and not conducive to low-cost antibody manufacturing. Therefore, one must rely on chemical sanitants to treat reusable materials such as resin and column housings. Just successfully implemented a sanitization procedure for Protein A chromatography capture in large-scale (500 liter) productions using a peracetic acid solution. After changing the Protein A resin used in this step, we experienced a series of contaminations at large-scale. To investigate these contaminations, we developed a small-scale model probing sanitant concentrations, hold duration, and potential resin-sanitant interactions. The data generated using this small-scale model informed concurrent large-scale column sanitization work, resulting in a sanitization procedure that successfully enabled a bioburden-free GMP continuous capture process.

Small-scale model for studying resin interactions with chemical sanitants

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.