Host cell protein (HCP): A multi-company collaboration: Views on "high risk" HCP: Presentation

This presentation compliments the papers and risk manage tool

The goal of the Host Cell Protein (HCP) Workstream is to deliver for industry alignment; building a common understanding of agency requirements for HCPs through benchmarking and gap analysis of guidance. To widen understanding of the risks associated with HCPs and what can be done to mitigate these risks during process development.

This poster available to 'Members Only' discusses:

  • Industry benchmarking
  • Understanding of what companies are doing in order to understand HCP risk through the stages of development
  • Risk assessment methodology and risk scoring tool to perform qualitative and semi-quantitative assessment of risk when dealing with HCPs
  • Case studies
  • Next steps.

 

Presented at

  • USP, March 2019
  • BEBPA 2019 HCP Conference, San Pedro, CA. May 2019
  • Bioprocessing Summit, Boston, MA, August 2019
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