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“HIGH-RISK” HOST CELL PROTEINS (HCPs): A MULTI-COMPANY COLLABORATIVE VIEW
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  • Marisa Jones,
  • Nisha Palackal,
  • Fengqiang Wang,
  • Georgeen Gaza-Bulseco,
  • Karen Hurkmans,
  • Yiwei Zhao,
  • Carmelata Chitikila,
  • Séverine Clavier,
  • Suli Liu,
  • Emily Menesale,
  • Nicole Schonenbach,
  • Satish Sharma,
  • Thomas Waerner,
  • Lei Zhang,
  • Patricia Connolly
Marisa Jones
GlaxoSmithKline
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Nisha Palackal
Regeneron Pharmaceuticals Inc
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Fengqiang Wang
Merck & Co Inc
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Georgeen Gaza-Bulseco
AbbVie Inc
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Karen Hurkmans
AbbVie Inc
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Yiwei Zhao
Immunogen Inc
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Carmelata Chitikila
Janssen Pharmaceutical Companies of Johnson and Johnson
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Séverine Clavier
Sanofi SA
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Suli Liu
Biogen Inc
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Emily Menesale
Biogen Inc
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Nicole Schonenbach
Pfizer Inc
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Satish Sharma
Bristol-Myers Squibb Co
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Thomas Waerner
Boehringer Ingelheim Pharma GmbH
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Lei Zhang
Bristol-Myers Squibb Co
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Patricia Connolly
BioPhorum
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Abstract

Host cell proteins (HCPs) are process-related impurities that may co-purify with biopharmaceutical drug products. Within this class of impurities there are some that are more problematic. These problematic HCPs can be considered high-risk and can include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or excipients used in formulation, and often are difficult-to-purify. Why should the biopharmaceutical industry worry about these high-risk host cell proteins? What approach could be taken to understand the origin of this co-purification and to deal with these high-risk HCPs? To answer these questions, the BioPhorum Development Group (BPDG) HCP Workstream initiated a collaboration among its 26-company team with the goal of industry alignment around high-risk HCPs. A sub team was formed, in which the members performed literature searches and discussed the information available around this topic. A survey to the BPDG HCP Workstream team members led to team discussions and insights into a list of frequently seen problematic HCPs. These HCPs were further classified based on their potential impact into different risk categories that could be beneficial to the biopharmaceutical industry for targeted monitoring of those HCP impurities in CHO-produced biologics to minimize risk to product quality, safety, and efficacy.

Peer review status:Published

14 Oct 2020Submitted to Biotechnology and Bioengineering
14 Oct 2020Submission Checks Completed
14 Oct 2020Assigned to Editor
14 Oct 2020Reviewer(s) Assigned
04 Nov 2020Review(s) Completed, Editorial Evaluation Pending
04 Nov 2020Editorial Decision: Revise Major
12 Mar 20211st Revision Received
18 Mar 2021Assigned to Editor
18 Mar 2021Submission Checks Completed
18 Mar 2021Reviewer(s) Assigned
27 Mar 2021Review(s) Completed, Editorial Evaluation Pending
27 Mar 2021Editorial Decision: Revise Minor
08 Apr 20212nd Revision Received
08 Apr 2021Assigned to Editor
08 Apr 2021Submission Checks Completed
09 Apr 2021Review(s) Completed, Editorial Evaluation Pending
09 Apr 2021Editorial Decision: Accept
30 Apr 2021Published in Biotechnology and Bioengineering. 10.1002/bit.27808