An interlaboratory capillary zone electrophoresis-UV study of various monoclonal antibodies, instruments, and ε-aminocaproic acid lots.

Autor: Wiesner R; Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany., Zagst H; Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany., Lan W; Bristol Myers Squibb, New Brunswick, New Jersey, USA., Bigelow S; Health Canada, Ottawa, Ontario, Canada., Holper P; AB SCIEX LLC, Redwood City, California, USA., Hübner G; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany., Josefsson L; Kantisto BV, Baarn, The Netherlands., Lancaster C; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA., Lo L; Bristol Myers Squibb, New Brunswick, New Jersey, USA., Lößner C; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany., Lu H; Health Canada, Ottawa, Ontario, Canada., Neusüß C; Faculty Chemistry, Hochschule Aalen, Aalen, Germany., Rüttiger C; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany., Schlecht J; Faculty Chemistry, Hochschule Aalen, Aalen, Germany., Schürrle P; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany., Selsam A; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany., van der Burg D; Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany.; Kantisto BV, Baarn, The Netherlands.; Department of Chemistry, School of Engineering Sciences in Chemistry, KTH Royal Institute of Technology, Stockholm, Sweden., Wang SC; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA., Zhu Y; Bristol Myers Squibb, New Brunswick, New Jersey, USA., Wätzig H; Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany., Sänger-van de Griend C; Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany.; Kantisto BV, Baarn, The Netherlands.; Department of Medicinal Chemistry, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden.
Jazyk: angličtina
Zdroj: Electrophoresis [Electrophoresis] 2023 Aug; Vol. 44 (15-16), pp. 1247-1257. Date of Electronic Publication: 2023 May 11.
DOI: 10.1002/elps.202200284
Abstrakt: 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.
(© 2023 The Authors. Electrophoresis published by Wiley-VCH GmbH.)
Databáze: MEDLINE
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