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An interlaboratory capillary zone electrophoresis-UV study of various monoclonal antibodies, instruments, and ε-aminocaproic acid lots
Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany.
Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany.
Bristol Myers Squibb, New Brunswick, New Jersey, USA.
Health Canada, Ottawa, Ontario, Canada.
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2023 (English)In: Electrophoresis, ISSN 0173-0835, E-ISSN 1522-2683, Vol. 44, no 15-16, p. 1247-1257Article in journal (Refereed) Published
Abstract [en]

Capillary zone electrophoresis ultraviolet (CZE-UV) has become increasingly popular for the charge heterogeneity determination of mAbs and vaccines. The ε-aminocaproic acid (eACA) CZE-UV method has been used as a rapid platform method. However, in the last years, several issues have been observed, for example, loss in electrophoretic resolution or baseline drifts. Evaluating the role of eACA on the reported issues, various laboratories were requested to provide their routinely used eACA CZE-UV methods, and background electrolyte compositions. Although every laboratory claimed to use the He et al. eACA CZE-UV method, most methods actually deviate from He's. Subsequently, a detailed interlaboratory study was designed wherein two commercially available mAbs (Waters’ Mass Check Standard mAb [pI 7] and NISTmAb [pI 9]) were provided to each laboratory, along with two detailed eACA CZE-UV protocols for a short-end, high-speed, and a long-end, high-resolution method. Ten laboratories participated each using their own instruments, and commodities, showing excellence method performance (relative standard deviations [RSDs] of percent time-corrected main peak areas from 0.2% to 1.9%, and RSDs of migration times from 0.7% to 1.8% [n = 50 per laboratory], analysis times in some cases as short as 2.5 min). This study clarified that eACA is not the main reason for the abovementioned variations.

Place, publisher, year, edition, pages
Wiley , 2023. Vol. 44, no 15-16, p. 1247-1257
Keywords [en]
CZE-UV, eACA, interlaboratory trial, monoclonal antibodies, precision
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:kth:diva-338454DOI: 10.1002/elps.202200284ISI: 000985898400001PubMedID: 37079448Scopus ID: 2-s2.0-85159083356OAI: oai:DiVA.org:kth-338454DiVA, id: diva2:1812589
Note

QC 20231116

Available from: 2023-11-16 Created: 2023-11-16 Last updated: 2023-11-16Bibliographically approved

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van der Burg, Debbie

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