Industry guidelines for host cell protein impurity analysis emphasize the importance of process-specific and product-specific assessment to account for how the purification procedures and the therapeutic product may uniquely influence the impurities observed. HCP-Mass Spectrometry (HCP-MS) analysis is quickly becoming recognized as a practical, orthogonal approach to ELISA to achieve greater coverage and knowledge of the HCP profile of a biopharmaceutical product. Establishing a streamlined workflow for HCP-MS analysis can be challenging, given that the strategies and rationale for implementing HCP-MS will differ depending on the product, process(es) and other project-specific variables. This webinar will highlight the benefits and the limitations of key analysis criteria for scientists who are developing their HCP-MS detection strategy.

 

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