Accelerating Biologic And Bioconjugate Development: Key Bioassay Strategies For Successful IND Submission

Watch Erika Kovacs, Senior Director of Bioassay at Abzena, as she discusses critical considerations for developing stage-appropriate bioassays to support complex biologics and bioconjugates on the path to IND. Through real-world case studies, Dr. Kovacs shares insights on selecting the right assay based on the molecule’s mechanism of action and stage of development, applying developability assessments to guide lead candidate selection, and meeting the requirements for GMP potency testing.

Progressing a biologic or bioconjugate from discovery to IND is increasingly complex, particularly given the sophisticated modalities emerging today. To navigate this, a robust bioassay strategy is essential. Well-designed assays provide the comprehensive data needed to drive confident, data-informed decisions — ultimately increasing the chances of clinical success. However, assay development is a careful balancing act: it must closely mimic the intended pharmacology while maintaining sensitivity, robustness, accuracy, and precision. This webinar provides a practical overview of how to achieve that balance and ensure your assay strategy aligns with regulatory expectations and program goals at every development stage.