On-Demand Webinar

Best Practices for Process Development Using Small-scale
Millistak+® Filters

Duration: 1 Hour
Speakers: Kara Pizzelli, Process Development Sciences Group Manager, Merck

Abstract: Clarification of mammalian cell culture harvest remains an important step in biotherapeutic production. With advancements in capacity of depth-filtration media and the move towards single-use, clarification via two-step depth filtration is a common approach at scales up to 2000 L. Despite the proliferation of template approaches for purification of monoclonal antibodies, the process development activities for clarification unit operations can still be challenging in terms of designing a small scale experiment which is representative of the large scale. This is because it is not possible to know in advance of the small scale trials which ratio of primary to secondary clarification filter to use, the appropriate flow rate to use and when breakthrough will occur on the two filters. We discuss how to best standardize the process development approach for a two step clarification process to ensure the development of a robust, scalable unit operation while minimizing the necessary amount of process development work.

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