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. 2022 Nov;38(6):e3296.
doi: 10.1002/btpr.3296. Epub 2022 Aug 29.

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

Deepika Gollapudi  1 , Erwin Rosales-Zavala  1 , Vera B Ivleva  1 , Yanhong Yang  1 , Yile Li  1 , Sarah O'Connell  1 , Nicole A Doria-Rose  1 , Aakash Patel  1 , Daniel Blackstock  1 , Daniel B Gowetski  1 , Kevin Carlton  1 , Jason G D Gall  1 , Q Paula Lei  1
Affiliations

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

Deepika Gollapudi et al. Biotechnol Prog. 2022 Nov.

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.

Keywords: CAP256LS; capillary gel electrophoresis (CGE); heavy chain clipping; monoclonal antibody; protease.

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References

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