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Impact of next-generation high productivity perfusion cell culture process on host cell protein profile and a comparison with fed-batch cultures.
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  • Jiyoung Hong,
  • Minni Aswath,
  • Yuan Gao,
  • Daisie Ogawa,
  • Vaishali Sharma,
  • Min Zhu
Jiyoung Hong
Boehringer Ingelheim Fremont Inc
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Minni Aswath
Boehringer Ingelheim Corp USA
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Yuan Gao
Boehringer Ingelheim Corp USA
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Daisie Ogawa
Boehringer Ingelheim Corp USA
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Vaishali Sharma
Boehringer Ingelheim Corp USA
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Min Zhu
Boehringer Ingelheim Fremont Inc
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Abstract

Fed-batch culture currently represents the typical choice for the production of monoclonal antibodies (mAbs) in the biopharmaceutical industry. However, the implementation of perfusion culture process combined with continuous manufacturing has gained attention due to increased productivity and resource savings. In this paper, we compared the host cell protein (HCP) production and profile of mAb1 between fed-batch and perfusion culture processes. Our work demonstrated differences in HCP production based on the type of cell culture process for the first time. We focused on HCPs that get carried through the purification process and are present in the final drug substance at levels impacting antibody quality and stability. Perfusion process had lower HCP levels and enabled higher clearance of problematic HCPs compared to fed-batch suggesting a viable alternative process. Furthermore, our work demonstrates proof of concept of the impact of cell culture process on specific product quality and help to navigate the process design when we move from traditional fed-batch to next-generation perfusion cell culture.

Peer review status:UNDER REVIEW

14 Nov 2020Submitted to Biotechnology and Bioengineering
16 Nov 2020Assigned to Editor
16 Nov 2020Submission Checks Completed
24 Nov 2020Review(s) Completed, Editorial Evaluation Pending