Pihl, Susanne, van der Strate, Barry, Golob, Michaela, Vermet, Laurent, Jaitner, Birgit, Goodman, Joanne , Scheel Fjording, Marianne and Timmerman, Philip (2018) EBF recommendation on practical management of critical reagents for PK ligand-binding assays. Bioanalysis, 10 (19). pp. 1557-1565. ISSN 17576199

Abstract

Critical reagents play a crucial role in ligand-binding assays; the robustness and reliability of an assay is defined by the quality and long-term availability of these reagents. However, neither regulatory guidelines nor relevant scientific papers provide clear directions for set-up, life cycle management and, more importantly, the acceptance criteria required for the testing of the critical reagents for pharmacokinetic, biomarker and immunogenicity assays. The ambiguity from current guidelines can be a challenge for the bioanalytical community. Members of the European Bioanalysis Forum community undertook a more pragmatic approach on how to assess the impact of critical reagents. In this paper, a review and corresponding gap analysis of the current guidelines and relevant papers will be provided as well as decision trees proposed for lot-to-lot changes of critical reagents for pharmacokinetic assays.

Item Type:	Article
Keywords:	antibodies critical reagents ligand-binding assays major change minor change PK assay
Date Deposited:	02 Apr 2019 00:45
Last Modified:	02 Apr 2019 00:45
URI:	https://oak.novartis.com/id/eprint/37242