title: Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents.
abstract: Critical reagents are essential components of ligand binding assays (LBAs) and are utilized throughout the process of drug discovery, development, and post-marketing monitoring. Successful lifecycle management of LBA critical reagents minimizes assay performance problems caused by declining reagent activity and can mitigate the risk of delays during preclinical and clinical studies. Proactive reagent management assures adequate supply. It also assures that the quality of critical reagents is appropriate and consistent for the intended LBA use throughout all stages of the drug development process. This manuscript summarizes the key considerations for the generation, production, characterization, qualification, documentation, and management of critical reagents in LBAs, with recommendations for antibodies (monoclonal and polyclonal), engineered proteins, peptides, and their conjugates. Recommendations are given for each reagent type on basic and optional characterization profiles, expiration dates and storage temperatures, and investment in a knowledge database system. These recommendations represent a consensus among the authors and should be used to assist bioanalytical laboratories in the implementation of a best practices program for critical reagent life cycle management.
authors.affiliation: Department of Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc, One Burtt Road, Andover, Massachusetts 01810, USA. Denise.OHara@Pfizer.com
authors.forename: Denise M
authors.initials: DM
authors.lastname: O'Hara
authors.forename: Valerie
authors.initials: V
authors.lastname: Theobald
authors.forename: Adrienne Clements
authors.initials: AC
authors.lastname: Egan
authors.forename: Joel
authors.initials: J
authors.lastname: Usansky
authors.forename: Murli
authors.initials: M
authors.lastname: Krishna
authors.forename: Julie
authors.initials: J
authors.lastname: TerWee
authors.forename: Mauricio
authors.initials: M
authors.lastname: Maia
authors.forename: Frank P
authors.initials: FP
authors.lastname: Spriggs
authors.forename: John
authors.initials: J
authors.lastname: Kenney
authors.forename: Afshin
authors.initials: A
authors.lastname: Safavi
authors.forename: Jeannine
authors.initials: J
authors.lastname: Keefe
mesh_terms: D000818:Animals; D055808:Drug Discovery / Q000379:methods / Q000639:trends; D006801:Humans; D007202:Indicators and Reagents / Q000737:chemistry* / Q000378:metabolism*; D008024:Ligands; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000378:metabolism*; D011485:Protein Binding / Q000502:physiology
chemical_list: D007202:Indicators and Reagents; D008024:Ligands; D004364:Pharmaceutical Preparations