Host cell proteins (HCP) constitute a major group of impurities for biologic drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability.
A broadly-reactive HCP ELISA should be used during the purification processes to ensure removal of HCPs and to demonstrate process consistency and final DS purity. Regulatory authorities are requesting biopharmaceutical companies employ orthogonal methods to demonstrate antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA used by a sponsor is fit for this purpose.
Antibody Affinity Extraction™ (AAE™), a novel method developed by Cygnus Technologies, is used to determine antibody coverage and reactivity to those HCPs that co-purify with DS. AAE is more predictive of the anti-HCP antibody performance in the HCP ELISA and facilitates identification of individual downstream HCPs.
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