The separation of impurities from the drug substance is important in any bioprocess whether used to manufacture penicillin or a monoclonal antibody. We studied difficult to remove host cell proteins in CHO cells with the goal of identifying host cell proteins that may be product associated with a number of monoclonal antibodies, that may copurify with products on various polishing resins, and that may significantly alter their expression as a function of cell age which offers important considerations as the field moves towards continuous bioprocessing. We identified more than 120 potentially problematic host cell proteins. We believe that at least one of these problematic host cell proteins may contribute to issues in the degradation of polysorbates which are commonly used in monoclonal antibody formulations. We will discuss how the identification of problematic host cell proteins can be used as an opportunity for cell line development efforts.

Difficult-to-remove CHO host cell protein impurities

253rd National Meeting (2017)

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