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Reshaping Cell Line Development and CMC Strategy for Fast Responses to Pandemic Outbreak
  • +5
  • Zheng Zhang,
  • Ji Chen,
  • Junghao Wang,
  • Qiao Gao,
  • Shurong Xu,
  • Li Zhang,
  • Jill Cai,
  • Weichang Zhou
Zheng Zhang
WuXi Biologics
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Ji Chen
WuXi Biologics
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Junghao Wang
WuXi Biologics
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Qiao Gao
WuXi Biologics
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Shurong Xu
WuXi Biologics
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Li Zhang
WuXi Biologics
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Jill Cai
WuXi Biologics
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Weichang Zhou
WuXi Biologics
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Abstract

The global pandemic outbreak, SARS-COV-2, which causes COVID-19, has coerced numerous pharmaceutical companies to sprint for the vaccine and therapeutic biologics development. Most of the therapeutic biologics are common human IgG antibodies, which were identified by next-generation sequencing with the B cells from the convalescent patients in less than one-month post-infection. While the global public health emergency calls for medications urgently, it saves lives to expedite the clinical trials of biologics as much as possible, hence the biologics development strategies are unprecedentedly challenged. Since the advent of therapeutic biologics, transfection, and selection strategy has been continuously improving for developing more robust cell lines with greater productivity and efficiency. Next-generation sequencing (NGS) has also been implemented into cell bank testing for acceleration. These recent advances enable us to rethink and reshape the chemistry, manufacturing and controls (CMC) strategy against the pandemic outbreaks, to start supplying cGMP materials for the life-saving clinical trials as soon as possible. We elucidated an accelerated CMC workflow for biologics against pandemics, including using cGMP-compliant pool materials for Phase I clinical trials, selecting the final clone with similar product quality as Phase I materials for late-stage development and commercial production and matching product quality among different manufacturing stages.

Peer review status:UNDER REVIEW

25 Nov 2020Submitted to Biotechnology and Bioengineering
27 Nov 2020Assigned to Editor
27 Nov 2020Submission Checks Completed
30 Nov 2020Review(s) Completed, Editorial Evaluation Pending