2020 DIA China Annual Meeting

With the progress of adaption of international standards, the government and industry of China are actively implementing the ICH guidelines and in recentyears, the biotech industry has been remarkable since it is associated with plenty of features. Therefore, the ICH Q5: Quality of Biotechnological Productsguidelines are drawing more attention. The objective of this session is to introduce the ICH Q5 updating progress and share application experience in the industry with major focus on ICH Q5A: ViralSafety Evaluation Of Biotechnology Products Derived From Cell Lines Of Human Or Animal Origin and Q5E: Comparability Of Biotechnological/BiologicalProducts Subject To Changes In Their Manufacturing Process. ICH Q5A guideline is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human oranimal origin (i.e., mammalian, avian, insect). This session will bring the insights of ICH EWG member and Janssen expert to discuss the modular viral clearanceand its application in biological processes and regulatory filings. With the help of modular claims, time and resources can be saved without compromising product quality and safety. ICH Q5E guideline is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Due to technical or business reasons, manufacturers of biotechnological/biological products frequently make changes to manufacturing processes while this guideline has significant importance for frequently changing manufacturing processes. Industry experts will be invited to share their key points of the updates in the industry and experience of implementing this guideline.