title: Method transfer for ligand-binding assays: recommendations for best practice.
abstract: To support clinical trials, bioanalytical methods are often transferred from one laboratory to another. With the rising number of large-molecule therapeutic proteins submitted for US FDA approval, the demand for large-molecule bioanalytical support and, subsequently, method transfer increases. Ligand-binding assays are the methods most commonly used to quantify endogenous and therapeutic proteins for the assessment of biomarkers and pharmacokinetic parameters. The goal of this review is to provide an overview of ligand-binding assay method transfer, essential parameters for partial method validation and to lay out a strategy to increase the chance of success. The recommendations herein are based on a summary of current publications and the authors' specific experiences, to help increase workload efficiency, maintain positive collaborations with partners and meet program timelines.
authors.affiliation: Department of Pharmacokinetic & Drug Metabolism, Amgen Inc., Thousand Oaks, CA 91320, USA.
authors.forename: Danielle
authors.initials: D
authors.lastname: DeSimone
authors.forename: Judy Y
authors.initials: JY
authors.lastname: Shih
authors.forename: Han C
authors.initials: HC
authors.lastname: Gunn
authors.forename: Vimal
authors.initials: V
authors.lastname: Patel
authors.forename: Lennie
authors.initials: L
authors.lastname: Uy
authors.forename: Theingi M
authors.initials: TM
authors.lastname: Thway
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D003124:Colorimetry / Q000592:standards; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D017408:Guidelines as Topic; D007753:Laboratories; D008024:Ligands; D008163:Luminescent Measurements / Q000592:standards; D004364:Pharmaceutical Preparations / Q000378:metabolism* / Q000592:standards; D011506:Proteins / Q000378:metabolism / Q000493:pharmacokinetics / Q000592:standards; D018581:Technology Transfer; D016526:Workload / Q000191:economics
chemical_list: D015415:Biomarkers; D008024:Ligands; D004364:Pharmaceutical Preparations; D011506:Proteins