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An interlaboratory ...
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Wiesner, RebeccaInstitute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany
(författare)
An interlaboratory capillary zone electrophoresis-UV study of various monoclonal antibodies, instruments, and ε-aminocaproic acid lots
- Artikel/kapitelEngelska2023
Förlag, utgivningsår, omfång ...
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Wiley,2023
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:kth-338454
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https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-338454URI
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https://doi.org/10.1002/elps.202200284DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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QC 20231116
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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.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Zagst, HolgerInstitute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany
(författare)
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Lan, WenkuiBristol Myers Squibb, New Brunswick, New Jersey, USA
(författare)
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Bigelow, StewartHealth Canada, Ottawa, Ontario, Canada
(författare)
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Holper, PeterAB SCIEX LLC, Redwood City, California, USA
(författare)
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Hübner, GöranBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
(författare)
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Josefsson, LeilaKantisto BV, Baarn, The Netherlands
(författare)
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Lancaster, ClaireRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA
(författare)
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Lo, LiliBristol Myers Squibb, New Brunswick, New Jersey, USA
(författare)
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Lößner, ChristopherBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
(författare)
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Lu, HuixinHealth Canada, Ottawa, Ontario, Canada
(författare)
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Neusüß, ChristianFaculty Chemistry, Hochschule Aalen, Aalen, Germany
(författare)
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Rüttiger, CarolinBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
(författare)
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Schlecht, JohannesFaculty Chemistry, Hochschule Aalen, Aalen, Germany
(författare)
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Schürrle, PhilippBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
(författare)
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Selsam, AlexanderBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
(författare)
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van der Burg, DebbieKTH,Tillämpad fysikalisk kemi,Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany; Kantisto BV, Baarn, The Netherlands(Swepub:kth)u1wdmob2
(författare)
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Wang, Shao ChunRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA
(författare)
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Zhu, YunxiaoBristol Myers Squibb, New Brunswick, New Jersey, USA
(författare)
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Wätzig, HermannInstitute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany
(författare)
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Sänger-van de Griend, CariInstitute 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
(författare)
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Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, GermanyBristol Myers Squibb, New Brunswick, New Jersey, USA
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Electrophoresis: Wiley44:15-16, s. 1247-12570173-08351522-2683
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Wiesner, Rebecca
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Zagst, Holger
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Lan, Wenkui
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Bigelow, Stewart
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Holper, Peter
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Hübner, Göran
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visa fler...
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Josefsson, Leila
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Lancaster, Clair ...
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Lo, Lili
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Lößner, Christop ...
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Lu, Huixin
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Neusüß, Christia ...
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Rüttiger, Caroli ...
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Schlecht, Johann ...
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Schürrle, Philip ...
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Selsam, Alexande ...
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van der Burg, De ...
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Wang, Shao Chun
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Zhu, Yunxiao
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Wätzig, Hermann
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Sänger-van de Gr ...
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