Despite much progress in monoclonal antibody (mab) process development, primary clarification is still a challenging issue.  As timelines shorten and cost considerations become more pressing, harvest filtration is still an area needing improvement and predictability. Filter selection and area determination are time consuming and problems still occur, especially when changing production scales. Our goal is to find the characteristics of filter feed streams and develop a better understanding of factors impacting primary filtration. With this in mind, we have looked at multiple factors in mab cell culture process, centrifugation at bench and manufacturing scale, and filtration by depth and absolute filters.  We show the impact of varying parameters such as viable and non-viable cell density, accumulating cell debris, antifoam and particle size distribution on filterability of mab cell culture supernatants generated by different centrifuges at different scales.<br/>

Factors impacting filterability during primary clarification of monoclonal antibodies

253rd National Meeting (2017)

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