Anderka, Oliver, Graf, Tobias, Seisenberger, Christina, Wiedmann, Michael and Wohlrab, Stefanie (2021) Best practices on critical reagent characterization, qualification, and life cycle management for HCP immunoassays. Biotechnology and Bioengineering. ISSN 0006-35921097-0290

Abstract

The performance of immunoassays for the detection and quantification of host cell proteins (HCPs) in biopharmaceuticals depends on the quality of the critical assay reagents. Not only their preparation, but also a stringent life-cycle management, including reagent qualification, requalification and replacement, plays a crucial role in ensuring consistent and reliable results. To provide a cross-industry perspective on HCP reagent management, we conducted a survey on common practices among several pharmaceutical and biotech companies. Based on its outcome, as well as informed by a corresponding roundtable session (“Managing critical reagents over time”) at the BioPharmaceutical Emerging Best Practices Association (BEBPA) HCP conference in 2019, this work presents specific recommendations and proven concepts to support immunoassay reagent management for monitoring HCPs.

Item Type:	Article
Keywords:	ELISA, host cell protein, critical reagents, Immunoassay, reagent life-cycle management, qualification
Date Deposited:	04 Aug 2021 00:45
Last Modified:	04 Aug 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44856