Aug 18, 2025 · Host cell proteins (HCPs) are process-related impurities derived from host organisms used for recombinant protein production in biopharmaceutical manufacturing. The …

During the purification process, a majority of HCPs are removed from the final product. Residual HCPs that copurify with the manufactured antibody therapy, even at a low level, can elicit …

Different host cell lines, including mammalian, yeast, bacteria, plant, or insect, and cell-free systems can be used for expressing recombinant proteins. The choice of host cells may be...

Nov 1, 2024 · In the INTRODUCTION AND SCOPE section, the term ‘Residual HCP ELISA’ is being revised to ‘HCP ELISA’ to align with the Expert Committee’s decision on a public …

Jul 25, 2024 · The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect information and comments on evaluating and mitigating the immunogenicity risk of …

Apr 29, 2025 · Even at low levels, these residual proteins may trigger immune responses or impact drug stability, making their removal essential. To ensure product safety and efficacy, …

It provides best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS). The chapter supports regulatory …

Aug 4, 2025 · Most protein therapeutics are manufactured in nonhuman host cells; therefore, one of the major concerns of the presence of residual HCPs is the potential for any one or more of …

In response to stakeholder feedback on the need for best practices for the implementation of MS-based HCP analysis, USP created an Expert Panel of industry representatives and FDA …

Feb 12, 2025 · The United States Pharmacopeia (USP) has identified necessary minor corrections to General Chapter <1132.1> Residual Host Cell Protein Measurement in …