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Identification and quantification of host cell proteins in biopharmaceutical products

December 6, 2023

With the steady increase of industry regulators requesting host cell protein (HCP) quantification by techniques orthogonal to ELISA, UHPLC-MS has become the technique of choice for many pharmaceutical companies. Implementation of a UHPLC-MS-based approach offers significant advantages, allowing for identification and relative quantification of individual HCPs. A UHPLC-MS workflow can be applied across different therapeutic molecules and varied cell lines without the need for requalification and does not rely on the consistency of any product-specific reagents. A data-rich UHPLC-MS approach is ideal for facilitating in-process development decisions and for downstream HCP monitoring.