Precision; Repeatability; Reproducibility; System suitability test; Tryptic digest
Abstract :
[en] 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.
Barbas, Coral; CEMBIO San Pablo-CEU University, Madrid, Spain
Lopez-Gonzalvez, Angeles; CEMBIO San Pablo-CEU University, Madrid, Spain
Garcia, Antonia; CEMBIO San Pablo-CEU University, Madrid, Spain
Benevente, Fernando; University of Barcelona, Dept. of Analytical Chemistry, Barcelona, Spain
Sanz-Nebot, Victoria; University of Barcelona, Dept. of Analytical Chemistry, Barcelona, Spain
Blanc, Tim; Eli Lilly and Company, Bioanalytical Science, Branchburg, NJ, USA
Freckleton, Gordon; Eli Lilly and Company, Bioanalytical Science, Branchburg, NJ, USA
Britz-McKibbin, Philip; McMaster University, Dept. of Chemistry & Chemical Biology, Hamilton, Canada
Shanmuganathan, Meera; McMaster University, Dept. of Chemistry & Chemical Biology, Hamilton, Canada
de l'Escaille, François; ANALIS s.a., Suarlée (NAMUR), Belgium
Far, Johann ; Université de Liège > Chemistry > Laboratory of Mass Spectrometry > Ph.D
Haselberg, Rob; VU University Amsterdam, Division of BioAnalytical Chemistry, Amsterdam, the Netherlands / University of Tasmania, School of Chemistry, Hobart, Australia
Huang, Sean; Amgen Inc., PKDM, Seattle, WA, USA
Huhn, Carolin; University of Tuebingen, Institute for Physical and Theoretical Chemistry, Tuebingen, Germany
Pattky, Martin; University of Tuebingen, Institute for Physical and Theoretical Chemistry, Tuebingen, Germany
Michels, David; Genentech, Inc., Protein Analytical Chemistry Department, San Francisco, CA, USA
Mou, Si; Genentech, Inc., Protein Analytical Chemistry Department, San Francisco, CA, USA
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