EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Susanne Pihl, Barry W. A. van der Strate, Michaela Golob, Laurent Vermet, Birgit Jaitner, Joanne Goodman, Marianne Scheel Fjording, Philip Timmerman*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1557-1566
Number of pages10
JournalBioanalysis
Volume10
Issue number19
DOIs
Publication statusPublished - Oct-2018
Externally publishedYes

Keywords

  • antibodies
  • critical reagents
  • ligand-binding assays
  • major change
  • minor change
  • PK assay
  • ANALYTE STABILITY
  • BIOANALYSIS
  • VALIDATION

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