Expression systems of either mammalian, yeast, or bacterial origin are commonly used as host cells for the production of biopharmaceuticals. As a consequence of using these systems, endogenous host cell proteins (HCPs) will inevitably copurify or will be coexpressed and contaminate the product material. It is a regulatory requirement to identify and monitor process-related impurities such as HCPs, and a qualitative and quantitative assessment of the components in the final drug product must be performed.
HCPs should be assessed early in product development to show that improvements in downstream purification through process development are having a positive impact on the levels of HCPs present, serving to ultimately improve the quality of the product. HCP-mass spectrometry (HCP-MS) analysis is an orthogonal approach to enzyme-linked immunosorbent assay (ELISA) and can be used to achieve greater coverage and knowledge of the HCP profile of a biopharmaceutical. The strategies and rationale for implementing HCP-MS analysis will differ depending on the product, process, and other project-specific variables.
This webinar will benefit all scientists considering adding MS to their HCP detection strategy by discussing topics including
- spectral library generation,
- sample selection for quantitative analysis, and
- MS data expectations, including advantages and limitations.
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