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Related Concept Videos

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Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
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"High-risk" host cell proteins (HCPs): A multi-company collaborative view.

Marisa Jones1, Nisha Palackal2, Fengqiang Wang3

  • 1GlaxoSmithKline, CMC Analytical, Structure & Function Characterization, Collegeville, Pennsylvania, USA.

Biotechnology and Bioengineering
|April 30, 2021
PubMed
Summary

High-risk host cell proteins (HCPs) are problematic impurities in biopharmaceuticals. This study identifies these critical HCPs and provides a risk-based strategy for their control in drug manufacturing.

Keywords:
Chinese hamster ovaryPLBL2cathepsinshigh-risk HCPshost cell proteinslipase(s)problematic HCPsprotein A

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Protein Chemistry
  • Analytical Chemistry

Background:

  • Host cell proteins (HCPs) are process-related impurities that can copurify with biopharmaceutical products.
  • Certain HCPs pose higher risks due to immunogenicity, biological activity, or enzymatic activity, potentially degrading products or excipients.
  • Some problematic HCPs are challenging to remove through standard purification processes.

Purpose of the Study:

  • To address industry concerns regarding high-risk HCPs in biopharmaceutical manufacturing.
  • To achieve industry alignment on identifying and managing problematic HCPs.
  • To develop a comprehensive control strategy for monitoring and eliminating high-risk HCPs.

Main Methods:

  • Literature searches and surveys to gather information on problematic HCPs.
  • Company experiences shared among a 26-company collaboration team.
  • Classification of high-risk HCPs based on potential impact and risk assessment.

Main Results:

  • Compilation of a list of frequently encountered problematic/high-risk HCPs.
  • Categorization of these HCPs into different risk levels based on their impact.
  • Development of a step-by-step recommendation for a control strategy.

Conclusions:

  • A collaborative effort has led to industry alignment on high-risk HCPs.
  • A risk-based approach is recommended for controlling problematic HCPs in biopharmaceutical processes.
  • Implementing this strategy can benefit the biopharmaceutical industry by improving product quality and safety.