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Bioanalytical Track

Building for Change: Technologies, Modalities: Panel Discussion

Wednesday, July 16, 2025
11:10 AM - 11:55 AM ET
Location: Vienna Ballroom: South, East + West
Bioanalytical Track
Traditional bridging immunoassays, such as semi-homogeneous ELISA, are commonly used to support clinical immunogenicity assessments. We found that these approaches failed to meet assay sensitivity and/or drug tolerance criteria when the therapeutic contains multiple domains such as with bispecific therapeutics We provide evidence to suggest that multivalent drug can form intramolecular complexes between the drug and the ADAs, which compromises using bridging assay methods. Instead, we provide a fit-for-purpose solution to support ADA assay development for multivalent bispecific programs, and this method can be applied broadly to drugs lacking effector function binding.

Learning Objectives:

  • Our data highlights the limitations of using bridging immunoassay to assess immunogenicity of multivalent BsAbs
  • We provide evidence to suggest that the intra-molecular complexes formed between the drug and anti-ID positive controls hinders ADA assessment when using bridging immunoassay format
  • We adopt a fit-for-purpose solution for ADA assay development to support immunogenicity assessment of multivalent BsAbs programs in the clinic.