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Chinese Journal of Chromatography
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Chinese Journal of Chromatography  2019, Vol. 37 Issue (6): 666-670    DOI: 10.3724/SP.J.1123.2018.12023
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Optimization of sample preparation condition for sodium dodecyl sulfate capillary electrophoresis of non-reduced monoclonal antibodies
LIU Zhendong2, GAO Tie1, XU Lingli1, YANG Yong2, WANG Qingmin2, CHEN Hongxu1
1. CE & Biopharma, Sciex, Beijing 100015, China;
2. Drug Research Institute of Qilu Pharmaceutical Co., Ltd., Jinan 250100, China
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Abstract 

Sodium dodecyl sulfate capillary electrophoresis has become the mainstream method for purity analysis of monoclonal antibodies because of its advantages of fast and high resolution. Sample preparation has a significant impact on the purity detection of non-reduced monoclonal antibodies. In order to optimize sample preparation, the purity of monoclonal antibodies of different types and batches in sample buffers with iodoacetamide and N-ethyl maleimide as sulfhydryl sealants and at pH 6.0-9.0 was investigated. It was found that in the two types of sulfhydryl sealants, the high pH sample buffer could affect the sealing effect of the sulfhydryl sealant and produce more antibody fragments. Conversely, under the low pH condition, the antibody fragments were fewer and the purities of monoclonal antibodies were higher. Therefore, the sample buffer with pH 6.0 is the optimal preparation condition for the purity detection of non-reduced monoclonal antibodies.

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Articles by authors
LIU Zhendong
GAO Tie
XU Lingli
YANG Yong
WANG Qingmin
CHEN Hongxu
Key wordsmonoclonal antibody   non-reduced   sodium dodecyl sulfate (SDS)   capillary electrophoresis (CE)   iodoacetamide (IAM)   N-ethylmaleimide (NEM)     
Received: 2018-12-25;
Cite this article:   
LIU Zhendong,GAO Tie,XU Lingli et al. Optimization of sample preparation condition for sodium dodecyl sulfate capillary electrophoresis of non-reduced monoclonal antibodies[J]. Chinese Journal of Chromatography, 2019, 37(6): 666-670.
 
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