Volumetric absorptive microsampling (VAMS®) in therapeutic protein quantification by LC-MS/MS: Investigation of anticoagulant impact on assay performance and recommendations for best practices in method development

•We describe the method development, validation, and a proof-of-concept non-human primate study of a LC–MS method for VAMS utilized to obtain PK data for a therapeutic mAb.•The first report to comprehensively evaluate VAMS technology and LC–MS analysis for mAbs in preclinical and clinical studies, and share our issue-driven experiences from fingerstick VAMS sample analysis.•Special considerations and best practices during method development and validation are proposed to ensure early detection of potential issues and appropriate implementation of VAMS in clinical studies.