Analytical characterization of broadly neutralizing antibody CAP256LS heavy chain clipping during manufacturing development

Deepika Gollapudi; Erwin Rosales‐Zavala; Vera B. IvlevaYanhong YangYile LiSarah OConnellNicole A. Doria‐RoseAakash PatelDaniel BlackstockDaniel B. GowetskiKevin CarltonJason G. D. GallQ. Paula Lei

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Analytical characterization of broadly neutralizing antibody CAP256LS heavy chain clipping during manufacturing development

机译：Analytical characterization of broadly neutralizing antibody CAP256LS heavy chain clipping during manufacturing development

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Abstract Broadly neutralizing antibody (bNAb) CAP256‐VRC26.25 (abbreviated CAP256LS), a human IgGI monoclonal antibody targeting the V1V2 site of the HIV‐1 envelope, has demonstrated high therapeutic potential as a broadly neutralizing monoclonal antibody against HIV‐1. During the process development, a heavy chain fragmentation (clipping) was observed, that led to a relative potency reduction. In this report, we highlighted a series of process and product mitigation strategies deployed to advance this product. We have detailed how analytical characterization tools, especially the microchip reduced capillary gel electrophoresis (CGE‐SDS), played a pivotal role in identifying the development issues and in providing measurements to guide implementation of mitigation strategies.

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《Biotechnology Progress》 |2022年第6期|n/a-n/a|共7页
作者
Deepika Gollapudi; Erwin Rosales‐Zavala; Vera B. IvlevaYanhong YangYile LiSarah OConnellNicole A. Doria‐RoseAakash PatelDaniel BlackstockDaniel B. GowetskiKevin CarltonJason G. D. GallQ. Paula Lei;
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Vaccine Production Program, VRC, NIAID, NIH;

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原文格式 PDF
正文语种英语
中图分类生物科学;
关键词
CAP256LS; capillary gel electrophoresis (CGE); heavy chain clipping; monoclonal antibody; protease;

Analytical characterization of broadly neutralizing antibody CAP256LS heavy chain clipping during manufacturing development

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