title: HRMS using a Q-Exactive series mass spectrometer for regulated quantitative bioanalysis: how, when, and why to implement.
abstract: High-resolution MS (HRMS) has seen an uptake in use for discovery qual/quan workflows, however, its utilization in late discovery/development has been slow. Past reports comparing HRMS to triple quadrupole (QQQ) instrumentation to date have indicated that HRMS instruments are capable of producing data acceptable for regulated bioanalysis, however lack the sensitivity required for sub ng/ml LLOQ assays. Recent advances in HRMS instrumentation have closed the sensitivity gap with QQQ and have even provided improved selectivity and sensitivity over QQQ SRM assays. Herein, the authors will describe how, when, and why HRMS (specifically Q-Exactive series mass spectrometers) should be considered for implementation in regulated quantitative bioanalysis assays.
authors.affiliation: Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Sturm
authors.affiliation: Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.
authors.forename: Barry R
authors.initials: BR
authors.lastname: Jones
authors.affiliation: Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Mulvana
authors.affiliation: Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Lowes
mesh_terms: D002138:Calibration; D055808:Drug Discovery / Q000379:methods; D006801:Humans; D012984:Software; D053719:Tandem Mass Spectrometry / Q000379:methods*
keywords: HRAM; HRMS; Q-Exactive; development; high-resolution MS; mass extraction window; orbitrap