Xtalks Spotlight Interview: How Can Potency Assays Ensure More Successful Outcomes?

Potency assays are critical to ensuring consistent, safe and effective biologics from early-stage development through BLA filing. Learn from Abzena’s experts, Dr. Erika Kovacs and Rekha Patel, about how to overcome assay variability and regulatory complexity. Watch their Xtalks Spotlight video interview to learn more:

Abzena offers a phase-appropriate GMP relative potency assay service, which demonstrates our focus on delivering scientifically robust and regulatorily aligned solutions throughout the drug development process. Relative potency assays measure a drug candidate’s biological activity compared to a reference standard, serving as a critical indicator of product quality and consistency.

Abzena streamlines the development of these assays by integrating MoA-reflective methods tailored to each phase of drug development. For instance, in early development to support cell line development (CLD) and formulation activities, a more high-throughput relative potency assay might focus on evaluating key binding activities, while later-phase assays demand true functional cell-based assays with higher accuracy and tighter acceptance criteria to comply with regulatory guidelines. This staged approach ensures assays are fit-for-purpose at each phase of drug development, delivering fully regulatory-compliant data efficiently.