Identification and quantification of host cell proteins in biopharmaceutical products

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.