Host cell proteins (HCPs) are impurities present in all therapeutics derived from biological sources, and as a critical quality attribute (CQA), they must be characterized in detail and controlled through the manufacturing process and in the final drug product.
The individual protein contaminants that make up the HCP profile may vary significantly among individual biologic products including cell and gene therapies and expression systems, even for very closely related molecules. As such, the HCP profile must be analyzed to identify even low levels of potentially concerning species in a biologic drug.
To ensure consistency of product manufacture and shelf-life stability, and to minimize potential adverse clinical reactions, significant attention must be paid to identifying HCPs that remain in a biologic product following purification. Once identified, HCPs are often monitored and the levels controlled by process development decisions, to consistently yield a safe and efficacious product.
While ELISA methods have historically been the main approach to detecting total HCP content, LC-MS based HCP detection methods have increasingly become an expected orthogonal standard in successful biologic development.
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