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用于高通量电荷变体分析的超音速IEF方法的开发。

Development of the SupersonicIEF Method for High-Throughput Charge Variant Analysis.

作者信息

McElroy Will, Heger Christopher D

机构信息

Applications Science, ProteinSimple, a Bio-Techne Brand, San Jose, California, USA.

出版信息

Electrophoresis. 2024 Nov;45(21-22):1968-1975. doi: 10.1002/elps.202400117. Epub 2024 Oct 14.

DOI:10.1002/elps.202400117
PMID:39402844
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11662200/
Abstract

The analysis of biopharmaceuticals for charge variants occurs from early-stage samples through formulation and process-development optimization. Higher throughput methods allow increased analysis of these samples to facilitate greater understanding of the samples and to better optimize their production and formulation. To enable higher throughput charge variant analysis, a new, rapid platform imaged capillary isoelectric focusing (icIEF) method was optimized to be two to three times faster than standard methods.

摘要

对生物制药电荷变体的分析贯穿于从早期样品到制剂及工艺开发优化的整个过程。更高通量的方法能够增加对这些样品的分析,从而有助于更深入地了解样品,并更好地优化其生产和制剂。为实现更高通量的电荷变体分析,一种新型快速平台成像毛细管等电聚焦(icIEF)方法得到了优化,其速度比标准方法快两到三倍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/577ef1d94e9f/ELPS-45--g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/6af633e0ffaa/ELPS-45--g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/64792febaeeb/ELPS-45--g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/a86ac78e655c/ELPS-45--g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/1ac9ff3b9218/ELPS-45--g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/aa37a9f813fe/ELPS-45--g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/ce81f90cffb9/ELPS-45--g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/577ef1d94e9f/ELPS-45--g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/6af633e0ffaa/ELPS-45--g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/64792febaeeb/ELPS-45--g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/a86ac78e655c/ELPS-45--g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/1ac9ff3b9218/ELPS-45--g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/aa37a9f813fe/ELPS-45--g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/ce81f90cffb9/ELPS-45--g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/df79/11662200/577ef1d94e9f/ELPS-45--g003.jpg

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Biopharmaceutical Manufacturing: Historical Perspectives and Future Directions.生物制药制造:历史视角与未来方向
Annu Rev Chem Biomol Eng. 2022 Jun 10;13:141-165. doi: 10.1146/annurev-chembioeng-092220-125832. Epub 2022 Mar 17.
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A platform method for charge heterogeneity characterization of fusion proteins by icIEF.
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Anal Biochem. 2022 Feb 1;638:114505. doi: 10.1016/j.ab.2021.114505. Epub 2021 Nov 29.
4
Capillary isoelectric focusing with UV fluorescence imaging detection enables direct charge heterogeneity characterization of erythropoietin drug products.毛细管等电聚焦与紫外荧光成像检测相结合,可直接对红细胞生成素药物产品进行电荷异质性表征。
J Chromatogr A. 2021 Apr 26;1643:462043. doi: 10.1016/j.chroma.2021.462043. Epub 2021 Mar 15.
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