Analytical strategies for identification and quantitation of heterodimers in co-formulated monoclonal antibody cocktails by native SEC-MS.

ABSTRACT: Co-formulation of two or more therapeutic monoclonal antibodies (mAbs) into one final drug product has gained significant popularity recently due to its numerous advantages, including enhanced efficacy, reduced overall adverse events, and improved patient convenience and compliance. However, the increased heterogeneity of mAb cocktails introduces additional challenges for both formulation development and analytical characterization. Specifically, the identification and quantitation of various dimer species in mAb cocktails is particularly challenging due to their low abundances and highly similar biophysical properties. Traditional analytical tools used for dimer analysis in mAb monotherapy products often lack the specificity needed to distinguish between heterodimers and homodimers. In th

SUBMITTER: Peng W 

PROVIDER: S-EPMC12314195 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature