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An interlaboratory ...
An interlaboratory capillary zone electrophoresis-UV study of various monoclonal antibodies, instruments, and ε-aminocaproic acid lots
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- Wiesner, Rebecca (författare)
- Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.
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- Zagst, Holger (författare)
- Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.
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- Lan, Wenkui (författare)
- Bristol Myers Squibb, New Brunswick, New Jersey, USA,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.;Bristol Myers Squibb, New Brunswick, NJ USA.
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- Bigelow, Stewart (författare)
- Health Canada, Ottawa, Ontario, Canada,Hlth Canada, Ottawa, ON, Canada.
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- Holper, Peter (författare)
- AB SCIEX LLC, Redwood City, California, USA
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- Hübner, Göran (författare)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
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- Josefsson, Leila (författare)
- Kantisto BV, Baarn, The Netherlands
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- Lancaster, Claire (författare)
- Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA,Regeneron Pharmaceut Inc, Tarrytown, NY USA.
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- Lo, Lili (författare)
- Bristol Myers Squibb, New Brunswick, New Jersey, USA
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- Lößner, Christopher (författare)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
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- Lu, Huixin (författare)
- Health Canada, Ottawa, Ontario, Canada
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- Neusüß, Christian (författare)
- Faculty Chemistry, Hochschule Aalen, Aalen, Germany
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- Rüttiger, Carolin (författare)
- Boehringer Ingelheim Pharm GmbH & Co KG, Biberach An Der Riss, Germany.;Hsch Aalen, Fac Chem, Aalen, Germany.
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- Schlecht, Johannes (författare)
- Faculty Chemistry, Hochschule Aalen, Aalen, Germany
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- Schürrle, Philipp (författare)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
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- Selsam, Alexander (författare)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
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- van der Burg, Debbie (författare)
- KTH,Tillämpad fysikalisk kemi,Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany; Kantisto BV, Baarn, The Netherlands,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.;Kantisto BV, Baarn, Netherlands.;KTH Royal Inst Technol, Sch Engn Sci Chem, Dept Chem, Stockholm, Sweden.
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- Wang, Shao Chun (författare)
- Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA,Regeneron Pharmaceut Inc, Tarrytown, NY USA.
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- Zhu, Yunxiao (författare)
- Bristol Myers Squibb, New Brunswick, New Jersey, USA
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- Wätzig, Hermann (författare)
- Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.;Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Beethovenstr 55, D-38106 Braunschweig, Germany.
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- Sänger-van de Griend, Cari, Dr (författare)
- Uppsala universitet,Analytisk farmaceutisk kemi,Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany.;Kantisto BV, Baarn, Netherlands.;Kantisto BV, Callenburglaan 22, NL-3742 MV Baarn, Netherlands.
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- Loessner, Christopher (författare)
- Boehringer Ingelheim Pharm GmbH & Co KG, Biberach An Der Riss, Germany.
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- Neusuess, Christian (författare)
- Hsch Aalen, Fac Chem, Aalen, Germany.
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Institute of Medicinal and Pharmaceutical Chemistry, Technische Universität Braunschweig, Braunschweig, Germany Tech Univ Carolo Wilhelmina Braunschweig, Inst Med & Pharmaceut Chem, Braunschweig, Germany (creator_code:org_t)
- Wiley, 2023
- 2023
- Engelska.
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Ingår i: Electrophoresis. - : Wiley. - 0173-0835 .- 1522-2683. ; 44:15-16, s. 1247-1257
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
- NATURVETENSKAP -- Kemi -- Analytisk kemi (hsv//swe)
- NATURAL SCIENCES -- Chemical Sciences -- Analytical Chemistry (hsv//eng)
Nyckelord
- CZE-UV
- eACA
- interlaboratory trial
- monoclonal antibodies
- precision
Publikations- och innehållstyp
- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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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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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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Loessner, Christ ...
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Neusuess, Christ ...
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Medicinska och f ...
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och Farmaceutiska ve ...
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- NATURVETENSKAP
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NATURVETENSKAP
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och Kemi
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och Analytisk kemi
- Artiklar i publikationen
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Electrophoresis
- Av lärosätet
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Kungliga Tekniska Högskolan
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Uppsala universitet