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Best practices on critical reagent characterization, qualification, and life cycle management for HCP immunoassays
Author(s) -
Graf Tobias,
Seisenberger Christina,
Wiedmann Michael,
Wohlrab Stefanie,
Anderka Oliver
Publication year - 2021
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.27881
Subject(s) - reagent , biopharmaceutical , session (web analytics) , immunoassay , biochemical engineering , business , engineering management , computer science , chemistry , microbiology and biotechnology , medicine , engineering , biology , advertising , antibody , immunology
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 HCP conference in 2019, this study presents specific recommendations and proven concepts to support immunoassay reagent management for monitoring HCPs.