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

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

Wiesner, Rebecca (author): Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany

Zagst, Holger (author): Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany

Lan, Wenkui (author): Bristol Myers Squibb, New Brunswick, New Jersey, USA

Bigelow, Stewart (author): Health Canada, Ottawa, Ontario, Canada

Holper, Peter (author): AB SCIEX LLC, Redwood City, California, USA

Hübner, Göran (author): Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany

Josefsson, Leila (author): Kantisto BV, Baarn, The Netherlands

Lancaster, Claire (author): Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA

Lo, Lili (author): Bristol Myers Squibb, New Brunswick, New Jersey, USA

Lößner, Christopher (author): Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany

Lu, Huixin (author): Health Canada, Ottawa, Ontario, Canada

Neusüß, Christian (author): Faculty Chemistry, Hochschule Aalen, Aalen, Germany

Rüttiger, Carolin (author): Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany

Schlecht, Johannes (author): Faculty Chemistry, Hochschule Aalen, Aalen, Germany

Schürrle, Philipp (author): Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany

Selsam, Alexander (author): Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany

van der Burg, Debbie (author): KTH,Tillämpad fysikalisk kemi,Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany; Kantisto BV, Baarn, The Netherlands

Wang, Shao Chun (author): Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA

Zhu, Yunxiao (author): Bristol Myers Squibb, New Brunswick, New Jersey, USA

Wätzig, Hermann (author): Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany

Sänger-van de Griend, Cari (author): 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

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Wiley, 2023
2023
English.
In: Electrophoresis. - : Wiley. - 0173-0835 .- 1522-2683. ; 44:15-16, s. 1247-1257

Related links:: https://doi.org/10.1...; show more...; https://urn.kb.se/re...; https://doi.org/10.1...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

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.

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Basic Medicine; and Pharmaceutical S ...

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By the university: Royal Institute of Technology

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

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