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Whitepaper

Challenging Host Cell Protein Assays for Improved Risk Mitigation

Rectangle Image
Whitepaper

Challenging Host Cell Protein Assays for Improved Risk Mitigation

Host Cell Proteins (HCPs) are a heterogeneous, complex group of proteins that derived from the host cell. Regulatory agencies examine each protein drug on a case-by-case basis to determine appropriate maximum acceptable levels of HCPs considering patient risk. Therefore, it is imperative to have an effective, robust analysis method that takes steps to reduce the negative effects that an increased level of protein impurities could cause.

Download this whitepaper to discover the answers to these top questions:

  • What is the best approach to determine coverage?
  • Some HCPs are known to bind mAbs. How can we detect these HCPs?
  • What are HCPs and why do they need to be removed from the product?

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