Charge variants characterization and release assay development for co-formulated antibodies as a combination therapy.

ABSTRACT: Combination therapy is a fast-growing strategy to maximize therapeutic benefits to patients. Co-formulation of two or more therapeutic proteins has advantages over the administration of multiple medications, including reduced medication errors and convenience for patients. Characterization of co-formulated biologics can be challenging due to the high degree of similarity in the physicochemical properties of co-formulated proteins, especially at different concentrations of individual components. We present the results of a deamidation study of one monoclonal antibody component (mAb-B) in co-formulated combination antibodies (referred to as COMBO) that contain various ratios of mAb-A and mAb-B. A single deamidation site in the complementarity-determining region of mAb-B was identified as a c

SUBMITTER: Cao M 

PROVIDER: S-EPMC6512943 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature