Rathi Kodihal
Scientist Takeda Pharmaceutical
Seminars
Thursday 30th April 2026
Potency Assay Development for a Novel ADC modality: A Phase-Appropriate Strategy
10:00 am
- Design and qualify an early-phase, MoA-relevant cell-based potency assay – capturing target binding, internalization, and payload-driven response.
- Adopt linear regression to model the concentration-response relationship — reducing bias and enabling accurate potency estimates across the working response range.
- Identify and resolve key technical challenges to ensure late-phase readiness for the selected candidate.
Tuesday 28th April 2026
Designing Robust, Mechanism-of-Action Driven Bioassays To Demonstrate Functional Integrity for Dual Payload & Bispecific ADCs & AOCs
Delve into translating biological complexity into robust, reproducible, and relevant bioassays that accurately reflect clinical function. Join this workshop to prove the functional integrity of next-generation ADCs & AOCs and meet regulatory expectations for critical quality attributes by:
- Deconstructing a complex ADC & AOC mechanism of action into testable functional units, ensuring the resulting potency assay is biologically relevant and measures the activity, leading to robust, meaningful potency methods
- Selecting and engineering of reproducible cell lines, focusing on promoter strength and banking strategies, to create a stable foundation that minimizes bioassay variability and ensures consistent, reliable potency data
- Designing bioassays for bispecific and dual-payload ADCs & AOCs to address the critical challenge of proving dual-target engagement, controlling complex modalities, and demonstrating functional integrity
