Recombinant biotherapeutics are generally produced using non-human host cells, with Chinese hamster ovary (CHO), murine myeloma, and Escherichia coli cell-lines most commonly used. During cell growth and harvest, endogenous proteins from these host cells are released that can detrimentally affect final drug product safety and efficacy. Therefore, these host cell proteins must be removed post-harvest through a series of purification steps. The guidelines within the U.S. Pharmacopeia state, “The product purification processes must be optimized to consistently remove as many HCPs as feasible, with the goal of making the product as pure as possible”.
Consequently, HCPs levels in monoclonal antibody (mAb) biotherapeutics must be determined prior to drug release.
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