Analytical characterization of broadly neutralizing antibody CAP256LS heavy chain clipping during manufacturing
Deepika Gollapudi1, Erwin Rosales-Zavala1, Vera B Ivleva1
1Vaccine Production Program, VRC, NIAID, NIH, Gaithersburg, Maryland, USA.
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.
