Principal Scientist Roche Diagnostics GmbH Penzberg, Bayern, Germany
The understanding of ADA specific drug domain binding can be critical for the development of T-cell-engager-bispecific drugs (TCBs). The biolayer interferometry is a useful tool for rapid characterization of ADA domain specificity assessment. This methodology allows sample analyses of multiple cycles with all domains in one run. ADAs directed either to the target-binding drug domain site or to the CD3 activation drug domain-binding site show different drug-ADA-complex formation. ADA drug domain binding data along with active PK assays and complex assays allows a better understanding of the impact on exposure and activity. These data helps the clinical team to de-risk and adapt mitigation strategies during early TCB clinical development.
Learning Objectives:
Upon completion, participant will be able to understand that ADA specific drug domain binding is critical for the development of bispecific T-cell engager drugs.
Upon completion, participant will be able to learn a methodology that allows rapid ADA-domain-characterization sample analyses of multiple cycles with all domains and drug in one run.
Upon completion, participant will be able to learn that ADAs directed to the target-binding site are more critical than ADAs directed to the CD3 activation drug domain-binding site.
Upon completion, participant will be able to assess the risk of ADA responses during early T-cell engager drug development .
