Bi/Multispecific antibodies: challenges in translation
23 Jun 2025
Bi/Multispecifics
- How do translational efficacy and safety assessments contribute to the selection of optimal molecules?
- Why is the successful development of pharmacologically and clinically relevant bioassays, along with a robust bioanalytical strategy, essential?
- How do complex mechanisms of action influence the need for multiple bioassay and bioanalytical assays for characterization?
- What types of assays may be necessary for characterization, and what specific functions do they assess (e.g., potency, cell-killing, cytokine secretion, receptor internalization, effector function, and immunogenicity)?
- How are the results of these assays translated into a clinical setting to inform dosing strategies?
- In what ways do dosing strategies, including starting dose justification and step-up dosing, rely on assay results?
