Dmytro LEONTIEV and Natalia VOLOVYK, Deputy Director for Science and Deputy Director for Quality, respectively, at the Ukrainian Scientific Pharmacopeial Center for Quality of Medicines, took part in the AQbD Symposium organised by Waters Corporation.

About the Symposium

The Symposium, conducted online on the 28th and 29th of November, presented an innovative and comprehensive look into the world of Analytical Quality by Design (AQbD). This symposium catered to a wide audience from the industry, regulatory bodies, and academia, highlighting the significance of AQbD in the current pharmaceutical landscape. The AQbD Symposium 2023 offered a platform for discussion on the latest trends and advancements in analytical procedure development.

Invited Speakers:

Nina Cauchon, Ph.D.Director, Regulatory Affairs, CMC, Amgen

Bryan Castle, Ph.D., Associate Vice President, Synthetic Molecule Design and Development, Eli Lilly

Ivan Sušanj, MPharm, Analytical Development and Stability Senior Scientist, JGL

Amanda Guiraldelli, Scientific Affairs Manager, US Pharmacopeia

Phil Borman, Ph.D., Director and Senior Fellow, GlaxoSmithKline

Paula Hong, Ph.D., Sr Manager, Research Support, Waters Corporation


Session 1: ICH Q2(R2)/Q14: Enhanced Approach to Analytical Procedures Development and Validation

This session delved into the nuances of AQbD as an enhanced method for analytical development. It emphasized the role of AQbD in reducing risks, producing robust methods, and its growing recognition by regulators for applications related to both small and large molecules, synthetic or biological drugs. The session also included updates on the ICH Q14 and Q2(R2) guidelines and their industry impact.

Session 2: Risk Mitigation in the Pharmaceutical QC Laboratory

The focus was on applying AQbD principles to mitigate risks in pharmaceutical QC laboratories. The session explored how using risk management tools and innovative technologies can ensure that analytical LC methods remain fit-for-purpose throughout their lifecycle.