Host Cell Protein contaminants in mAb manufacturing
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 immune …
General Chapter Residual Host Cell Protein Measurement in ...
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 comment received.
Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow …
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 host cell …
Host Cell Protein: Minimizing Impurities for Safe Biologics
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, manufacturers must …
Residual host cell proteins: sources, properties, detection methods …
Aug 18, 2025 · This review discusses the sources, properties, pretreatment and detection of residual HCPs in therapeutic products, along with current regulatory considerations and future advancements.
USP Announces Corrections to General Chapter <1132.1> on Residual Host ...
Feb 12, 2025 · The United States Pharmacopeia (USP) has identified necessary minor corrections to General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass …
USP <1132> Residual Host Cell Protein Measurement in …
USP General Chapter <1132> provides a comprehensive, informational framework for controlling residual host cell proteins (HCPs)—process-related impurities from the production cell line (e.g., …
USP 1132.1 : How to perform HCP analysis by MS - Alphalyse
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 compliance by …
Proteins & Peptides Residual Host Cell Protein (HCP) Analysis
Residual host cell protein (HCP) is a major class of process-related impurities that regulatory agencies require manufacturers to demonstrate have been eliminated during the development of …
U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Devices and Radiological Health Office of Combination Products ...