loading page

  • +12
  • 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

Corresponding Author:[email protected]

Author Profile
Nisha Palackal
Regeneron Pharmaceuticals Inc
Author Profile
Fengqiang Wang
Merck & Co Inc
Author Profile
Georgeen Gaza-Bulseco
AbbVie Inc
Author Profile
Karen Hurkmans
AbbVie Inc
Author Profile
Yiwei Zhao
Immunogen Inc
Author Profile
Carmelata Chitikila
Janssen Pharmaceutical Companies of Johnson and Johnson
Author Profile
Séverine Clavier
Sanofi SA
Author Profile
Suli Liu
Biogen Inc
Author Profile
Emily Menesale
Biogen Inc
Author Profile
Nicole Schonenbach
Pfizer Inc
Author Profile
Satish Sharma
Bristol-Myers Squibb Co
Author Profile
Thomas Waerner
Boehringer Ingelheim Pharma GmbH
Author Profile
Lei Zhang
Bristol-Myers Squibb Co
Author Profile
Patricia Connolly
Author Profile


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.
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 2021Submission Checks Completed
18 Mar 2021Assigned to Editor
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 2021Submission Checks Completed
08 Apr 2021Assigned to Editor
09 Apr 2021Review(s) Completed, Editorial Evaluation Pending
09 Apr 2021Editorial Decision: Accept
Aug 2021Published in Biotechnology and Bioengineering volume 118 issue 8 on pages 2870-2885. 10.1002/bit.27808