Characterization of high-molecular weight by-products in the production of a trivalent bispecific 2+1 heterodimeric antibody.

ABSTRACT: The development of increasingly complex antibody formats, such as bispecifics, can lead to the formation of increasingly complex high- and low-molecular-weight by-products. Here, we focus on the characterization of high molecular weight species (HMWs) representing the highest complexity of size variants. Standard methods used for product release, such as size exclusion chromatography (SEC), can separate HMW by-products from the main product, but cannot distinguish smaller changes in mass. Here, for the identification of the diverse and complex HMW variants of a trivalent bispecific CrossMAb antibody, offline fractionation, as well as production of HMW by-products combined with comprehensive analytical testing, was applied. Furthermore, HMW variants were analyzed regarding their chemical bi

SUBMITTER: Cramer DAT 

PROVIDER: S-EPMC9980510 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature