title: Interlaboratory study to evaluate the robustness of capillary electrophoresis-mass spectrometry for peptide mapping.
abstract: A collaborative study on the robustness and portability of a capillary electrophoresis-mass spectrometry method for peptide mapping was performed by an international team, consisting of 13 independent laboratories from academia and industry. All participants used the same batch of samples, reagents and coated capillaries to run their assays, whereas they utilized the capillary electrophoresis-mass spectrometry equipment available in their laboratories. The equipment used varied in model, type and instrument manufacturer. Furthermore, different types of sheath-flow capillary electrophoresis-mass spectrometry interfaces were used. Migration time, peak height and peak area of ten representative target peptides of trypsin-digested bovine serum albumin were determined by every laboratory on two consecutive days. The data were critically evaluated to identify outliers and final values for means, repeatability (precision within a laboratory) and reproducibility (precision between laboratories) were established. For relative migration time the repeatability was between 0.05 and 0.18% RSD and the reproducibility between 0.14 and 1.3% RSD. For relative peak area repeatability and reproducibility values obtained were 3-12 and 9-29% RSD, respectively. These results demonstrate that capillary electrophoresis-mass spectrometry is robust enough to allow a method transfer across multiple laboratories and should promote a more widespread use of peptide mapping and other capillary electrophoresis-mass spectrometry applications in biopharmaceutical analysis and related fields.
authors.affiliation: Agilent Technologies R&D and Marketing GmbH & Co. KG, Waldbronn, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Wenz
authors.affiliation: CEMBIO San Pablo-CEU University, Madrid, Spain.
authors.forename: Coral
authors.initials: C
authors.lastname: Barbas
authors.affiliation: CEMBIO San Pablo-CEU University, Madrid, Spain.
authors.forename: Ángeles
authors.initials: Á
authors.lastname: López-Gonzálvez
authors.affiliation: CEMBIO San Pablo-CEU University, Madrid, Spain.
authors.forename: Antonia
authors.initials: A
authors.lastname: Garcia
authors.affiliation: University of Barcelona, Dept. of Analytical Chemistry, Barcelona, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Benavente
authors.affiliation: University of Barcelona, Dept. of Analytical Chemistry, Barcelona, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: Sanz-Nebot
authors.affiliation: Eli Lilly and Company, Bioanalytical Science, Branchburg, NJ, USA.
authors.forename: Tim
authors.initials: T
authors.lastname: Blanc
authors.affiliation: Eli Lilly and Company, Bioanalytical Science, Branchburg, NJ, USA.
authors.forename: Gordon
authors.initials: G
authors.lastname: Freckleton
authors.affiliation: McMaster University, Dept. of Chemistry & Chemical Biology, Hamilton, Canada.
authors.forename: Philip
authors.initials: P
authors.lastname: Britz-McKibbin
authors.affiliation: McMaster University, Dept. of Chemistry & Chemical Biology, Hamilton, Canada.
authors.forename: Meera
authors.initials: M
authors.lastname: Shanmuganathan
authors.affiliation: ANALIS s.a, Suarlée (NAMUR), Belgium.
authors.forename: Francois
authors.initials: F
authors.lastname: de l'Escaille
authors.affiliation: University of Liege, Department of Chemistry, Mass Spectrometry Laboratory, Liege, Belgium.
authors.forename: Johann
authors.initials: J
authors.lastname: Far
authors.affiliation: VU University Amsterdam, Division of BioAnalytical Chemistry, Amsterdam, the Netherlands.|University of Tasmania, School of Chemistry, Hobart, Australia.
authors.forename: Rob
authors.initials: R
authors.lastname: Haselberg
authors.affiliation: Amgen Inc, PKDM, Seattle, WA, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Huang
authors.affiliation: University of Tuebingen, Institute for Physical and Theoretical Chemistry, Tuebingen, Germany.
authors.forename: Carolin
authors.initials: C
authors.lastname: Huhn
authors.affiliation: University of Tuebingen, Institute for Physical and Theoretical Chemistry, Tuebingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Pattky
authors.affiliation: Genentech, Inc, Protein Analytical Chemistry Department, San Francisco, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Michels
authors.affiliation: Genentech, Inc, Protein Analytical Chemistry Department, San Francisco, CA, USA.
authors.forename: Si
authors.initials: S
authors.lastname: Mou
authors.affiliation: Genentech, Inc, Protein Analytical Chemistry Department, San Francisco, CA, USA.
authors.forename: Feng
authors.initials: F
authors.lastname: Yang
authors.affiliation: Aalen University, Chemistry Department, Aalen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Neusuess
authors.affiliation: Aalen University, Chemistry Department, Aalen, Germany.
authors.forename: Nora
authors.initials: N
authors.lastname: Tromsdorf
authors.affiliation: Joint BioEnergy Institute, Lawrence Berkeley National Laboratory, Emeryville, CA, USA.
authors.forename: Edward E K
authors.initials: EEK
authors.lastname: Baidoo
authors.affiliation: Joint BioEnergy Institute, Lawrence Berkeley National Laboratory, Emeryville, CA, USA.
authors.forename: Jay D
authors.initials: JD
authors.lastname: Keasling
authors.affiliation: Amgen Inc, Drug Product Development, P&PD, Thousand Oaks, CA, USA.
authors.forename: SungAe Suhr
authors.initials: SS
authors.lastname: Park
keywords: Precision; Repeatability; Reproducibility; System suitability test; Tryptic digest