Getting Bispecific Antibody Release Testing Right

By Dr Fabio Rossi , Director of Analytics | Dr Camila Ortega, Director of Analytical Development | Dr Erika Kovacs, Sr. Director of Bioassay

Conventional monoclonal antibody release testing frameworks fall short when applied to complex, dual-targeting bioconjugates. Because bispecific antibodies rely on two functional arms, standard single-antigen binding assays run the risk of missing critical assembly defects or compromised binding domains. Establishing an effective release panel requires shifting away from generic assay catalogs and building testing strategies directly from the Target Product Profile.

A robust analytical strategy combines safety-driven microbiology with precise physicochemical testing and dual-binding functional assays. Implementing advanced tools—such as dual-binding ELISAs or cell-based potency assays—ensures both binding arms engage their intended targets simultaneously while catching chain mispairing and process impurities. Aligning these release assays early mitigates regulatory risk and guarantees batch-to-batch consistency. Explore the full article to discover practical frameworks for designing release testing panels tailored to complex antibody formats.