Interest in continuous processing is growing within the biopharma industry as a means of protein production. The most commonly mentioned platform for continuous processing utilizes perfusion for cell retention which allows the product to pass through a porous membrane. Continuous processing using perfusion technology has the dual benefits of high volumetric productivity and low product residence time within the bioreactor, thus making it an ideal platform for unstable molecules.<br/><br/>A continuous process was developed using an Alternating Tangential Flow (ATF) hollow fiber. However, due to the high cell mass a loss of sieving efficiency, a measure of how much product passes through the filter, was observed which had a significant impact on product residence time in addition to posing an increased risk of membrane fouling. Sieving efficiencies as low as 50% were observed over the course of a 30-day steady-state duration using a standard ATF filter. This talk will discuss the methods utilized to improve the sieving efficiency including changes to perfusion rate, membrane material type, and membrane pore size and the associated impact on the process performance.

Developing a continuous upstream platform: Ensuring process and product consistency by maximizing ATF sieving efficiency

2019 Spring National Meeting

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