title: Life cycle management of critical ligand-binding reagents.
abstract: Bioanalytical laboratories develop and validate ligand-binding assays (LBA) used to quantify the concentration of analytes of interest in various buffers and relevant biological matrices. The building blocks of LBA are reagents that recognize molecular and structural motifs on ligands, which are combined in various LBA formats to minimize biological matrix interferences and specifically detect and quantify the analyte of interest. The use of these LBA-requiring critical reagents, can span decades as programs mature to commercialization. Since critical reagents are generated mostly from biological systems, attention to their life cycle management, quality, characterization and sustainability are vital to the success of bioanalytical laboratories. Integrating de novo reagent generation, reagent biophysical characterization, LBA development, validation, and use, with reagent resupply processes leverages interdisciplinary activities and ensures smooth operations of a bioanalytical laboratory.
authors.affiliation: Department of Pharmacokinetics, Dynamics & Metabolism, Pfizer Inc., One Burtt Road, Andover, MA 01810, USA. denise.o'hara@pfizer.com.
authors.forename: Denise M
authors.initials: DM
authors.lastname: O'Hara
authors.forename: Valerie
authors.initials: V
authors.lastname: Theobald
mesh_terms: D000818:Animals; D006801:Humans; D007202:Indicators and Reagents / Q000032:analysis*; D008024:Ligands; D011786:Quality Control
chemical_list: D007202:Indicators and Reagents; D008024:Ligands