Evaluating the Immunogenicity Risk of Host Cell Proteins in …
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 …
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 …
USPNF810G_GC 1132_2017-01 - US Pharmacopeia (USP)
Residual HCPs have the potential to affect product quality, safety, and efficacy; therefore, the quantity of HCPs should be low. The product purification processes must be optimized to …
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 …
The future of host cell protein (HCP) identification during process ...
Development and qualification of a high sensitivity, high throughput Q‐PCR assay for quantitation of residual host cell DNA in purification process intermediate and drug substance samples.
INDs for these products should be submitted to CBER’s Office of Cellular, Tissue and Gene Therapies (OCTGT). FDA’s guidance documents, including this guidance, do not establish …
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, …
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 …
Host Cell Proteins - FDA seeks Comments on Immunogenicity …
Sep 24, 2024 · The issue of residues of host cell proteins (HCPs) plays an important role in the manufacture of peptide products. In July, the FDA called for comments via the Federal …
Host cell protein profiling of commercial therapeutic protein …
Exploring sample preparation and data evaluation strategies for enhanced identification of host cell proteins in drug products of therapeutic antibodies and Fc-fusion proteins.