Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi - Seguridad Mania.com - España y América Latina

Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production • Safety assessment of extractables and leachables is often based on assumption that E&L are highly toxic • Most common extractables from about 40 sets of study data indicates that none of them is part of “cohort of concern” per ICH M7 guideline. • Safety profiles of common extractables from common single use systems can be used to design a risk-based approach for future materials. Presented by Ping Wang, Director at Johnson & Johnson Ping Wang is a Director with Janssen R&D. He has been leading Janssen’s effort in the evaluation, selection and risk assessment related to polymeric materials used in the manufacturing, packaging and delivery of biologics, small molecules and transdermal drug products for the past ten years. His main interests and expertise are risk based material evaluation, E&L strategies and methodologies, single use systems, biocompatibility, biologics drug development, analytical technologies, regulatory implications and toxicological assessment of impurities. He is a board member of Extractables and Leachables Safety Information Exchange (ELSIE) Consortium. As an active member of Biophorum Operations Group (BPOG), he was a key contributor to the BPOG’s standardized extractable protocol, and the best practice guide for leachable risk assessment. He earned a PhD in pharmacy, received a Regulatory Affairs Certificate (RAC), and an MBA degree.