CMC Workshop 2015

This session will look at some of the issues arising in managing risks for large (biological) molecules, mainly from the perspective of QbD. ICH guidelines detail approaches to risk management, however interpretation of these concepts have not always been consistently applied to the development of control strategies for biological substances. Of particular importance is providing assurance that Critical Quality Attributes have been appropriately identified and placed in the control strategy. Risk ranking and filtering is an important tool for this purpose, yet other tools can be employed to achieve this. Speakers with industry and regulatory experience will share their perspectives on how this may be applied for innovator and biosimilar products.