PMID- 37079448
OWN - NLM
STAT- MEDLINE
DCOM- 20230817
LR  - 20230817
IS  - 1522-2683 (Electronic)
IS  - 0173-0835 (Linking)
VI  - 44
IP  - 15-16
DP  - 2023 Aug
TI  - An interlaboratory capillary zone electrophoresis-UV study of various monoclonal 
      antibodies, instruments, and epsilon-aminocaproic acid lots.
PG  - 1247-1257
LID - 10.1002/elps.202200284 [doi]
AB  - Capillary zone electrophoresis ultraviolet (CZE-UV) has become increasingly 
      popular for the charge heterogeneity determination of mAbs and vaccines. The 
      epsilon-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.
CI  - (c) 2023 The Authors. Electrophoresis published by Wiley-VCH GmbH.
FAU - Wiesner, Rebecca
AU  - Wiesner R
AD  - Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitat 
      Braunschweig, Braunschweig, Germany.
FAU - Zagst, Holger
AU  - Zagst H
AD  - Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitat 
      Braunschweig, Braunschweig, Germany.
FAU - Lan, Wenkui
AU  - Lan W
AD  - Bristol Myers Squibb, New Brunswick, New Jersey, USA.
FAU - Bigelow, Stewart
AU  - Bigelow S
AD  - Health Canada, Ottawa, Ontario, Canada.
FAU - Holper, Peter
AU  - Holper P
AD  - AB SCIEX LLC, Redwood City, California, USA.
FAU - Hubner, Goran
AU  - Hubner G
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
FAU - Josefsson, Leila
AU  - Josefsson L
AD  - Kantisto BV, Baarn, The Netherlands.
FAU - Lancaster, Claire
AU  - Lancaster C
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
FAU - Lo, Lili
AU  - Lo L
AD  - Bristol Myers Squibb, New Brunswick, New Jersey, USA.
FAU - Lossner, Christopher
AU  - Lossner C
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
FAU - Lu, Huixin
AU  - Lu H
AUID- ORCID: 0000-0003-1553-5529
AD  - Health Canada, Ottawa, Ontario, Canada.
FAU - Neususs, Christian
AU  - Neususs C
AD  - Faculty Chemistry, Hochschule Aalen, Aalen, Germany.
FAU - Ruttiger, Carolin
AU  - Ruttiger C
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
FAU - Schlecht, Johannes
AU  - Schlecht J
AD  - Faculty Chemistry, Hochschule Aalen, Aalen, Germany.
FAU - Schurrle, Philipp
AU  - Schurrle P
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
FAU - Selsam, Alexander
AU  - Selsam A
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
FAU - van der Burg, Debbie
AU  - van der Burg D
AUID- ORCID: 0000-0002-3525-4372
AD  - Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitat 
      Braunschweig, Braunschweig, Germany.
AD  - Kantisto BV, Baarn, The Netherlands.
AD  - Department of Chemistry, School of Engineering Sciences in Chemistry, KTH Royal 
      Institute of Technology, Stockholm, Sweden.
FAU - Wang, Shao-Chun
AU  - Wang SC
AD  - Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
FAU - Zhu, Yunxiao
AU  - Zhu Y
AD  - Bristol Myers Squibb, New Brunswick, New Jersey, USA.
FAU - Watzig, Hermann
AU  - Watzig H
AUID- ORCID: 0000-0002-7456-0612
AD  - Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitat 
      Braunschweig, Braunschweig, Germany.
FAU - Sanger-van de Griend, Cari
AU  - Sanger-van de Griend C
AUID- ORCID: 0000-0001-8409-4443
AD  - Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitat 
      Braunschweig, Braunschweig, Germany.
AD  - Kantisto BV, Baarn, The Netherlands.
AD  - Department of Medicinal Chemistry, Faculty of Pharmacy, Uppsala University, 
      Uppsala, Sweden.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230511
PL  - Germany
TA  - Electrophoresis
JT  - Electrophoresis
JID - 8204476
RN  - 0 (Antibodies, Monoclonal)
RN  - U6F3787206 (Aminocaproic Acid)
RN  - 0 (Electrolytes)
SB  - IM
MH  - *Antibodies, Monoclonal/analysis
MH  - *Aminocaproic Acid
MH  - Electrophoresis, Capillary/methods
MH  - Electrolytes
OTO - NOTNLM
OT  - CZE-UV
OT  - eACA
OT  - interlaboratory trial
OT  - monoclonal antibodies
OT  - precision
EDAT- 2023/04/20 18:41
MHDA- 2023/08/17 06:42
CRDT- 2023/04/20 12:43
PHST- 2023/03/29 00:00 [revised]
PHST- 2022/12/07 00:00 [received]
PHST- 2023/04/12 00:00 [accepted]
PHST- 2023/08/17 06:42 [medline]
PHST- 2023/04/20 18:41 [pubmed]
PHST- 2023/04/20 12:43 [entrez]
AID - 10.1002/elps.202200284 [doi]
PST - ppublish
SO  - Electrophoresis. 2023 Aug;44(15-16):1247-1257. doi: 10.1002/elps.202200284. Epub 
      2023 May 11.