Application of ICH Q11 Principles in Biotherapeutic Drug Substance Development.pdf

5th DIA China Annual Meeting – Patient Safety - A Sustained Focus from Scientific Ideas to Innovative Medicines May 12-15, 2013 Beijing, China Application of ICH Q11 Principles in Biotherapeutic Drug Substance Development Anthony Ridgway, Ph.D. Senior Regulatory Scientist Biologics and Genetic Therapies Directorate, Health Canada ?3 ? The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. ? These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Disclaimer The 5th Annual Meeting: Patient Safety - A Sustained Focus from Scientific Ideas to Innovative Medicines May 12-15, 2013 Health Products and Food Branch Presentation Outline ?Some terminology ?Challenges applying QbD to biologics ? ICH Q11: Development and manufacturing of Drug Substances – chemical and biotechnological/biological entities ?What might we see and when ? Issues and key messages Health Products and Food Branch What is Pharmaceutical Quality? ? All definitions embody principles of consistency in producing product of intended performance, attributes and composition. ? Suitability of a drug substance or the subsequent drug product for its intended use; includes attributes of identity, purity and strength (- ICH Q6A) ? An acceptably low