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Daris, Kristi

Gramlich, Paul

Vyas, Supal

Yam, Pheng

English

Engineering Conferences International

Thursday, April 27, 2023                              Session 7: Cell Culture for Integrated and Continuous Bioprocessing MAINTAINING PRODUCTIVITY OVER EXTENDED DURATIONS FOR PERFUSION PROCESSES  Paul Gramlich, Amgen, USA gramlich@amgen.com Supal Vyas, Amgen, USA Pheng Yam, Amgen, USA Kristi Daris, Amgen, USA   Key Words: Perfusion, stability, productivity, intensification  Manufacturing process platforms in the biopharmaceutical industry are evolving from low biomass, large volume fed-batch processes to include continuous, sustained high biomass, small volume processes. This transition provides the opportunity for advancing innovative solutions to new process development challenges. During the development of one such intensified process, several different cell culture process modes were evaluated: steady state perfusion, non-steady state intensified batch and fed-batch. Productivity remained constant through the duration of the culture for the non-steady state intensified batch and fed-batch process modes but decreased in the steady state perfusion mode. Interestingly, the overall productivity was found to correlate negatively with culture viabilities. Investigation of this decrease in productivity revealed a correlation to cell age and subsequently to a decline in copy number. Implementation of selective medium for perfusion effectively reversed the decline in productivity, maintaining it without impact to product quality. As platforms in the biopharmaceutical industry continue to evolve, these solutions can be leveraged in the development of a robust perfusion process  

Maintaining productivity over extended durations for perfusion processes

https://dc.engconfintl.org/cgi/viewcontent.cgi?filename=0&article=1047&context=ccexviii&type=additional

Maintaining productivity over extended durations for perfusion processes

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Engineering Conferences International