"Yes, understanding the structure–function relationship of heterogeneous biomolecules is essential for setting patient-centric specifications. It helps identify which structural variations truly affect efficacy, safety (such as immunogenicity), allowing tighter control on high-risk attributes and more flexibility on others. This scientific understanding supports risk-based decisions, ensuring specifications reflect clinical relevance rather than just manufacturing variability."

Learn more from Dr. Patanachai “Kong” Limpikirati. by viewing his presentation “Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics” during the Expert Forum: Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B

"This would be of great help for sure, better knowing and modelling the relationship between structure and function and above all the predictive impact on the safety and efficacy to patient. Leveraging structural modelling, functional modelling and physiological modelling using various data analyses pathways is certainly a future."

Learn more from Dr. Eric Rozet by viewing his presentation “Patient-Centric Commercial Specifications for Biotherapeutic Products, Strategies and Case studies” during the Expert Forum: Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B