Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi

Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production Presented by Ping Wang, Director at Johnson & Johnson • 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. Followed by Current Trends in Extractables and Leachables Testing from Manufacturing Equipment to Single Use Manufacturing Components Presented by Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services There are many types of components that a drug formulation may contact during a typical manufacturing process.  This can range from large volume mixing vessels to filters, tubing and other smaller components.  More recently the use of Single Use Systems (SUS) have been steadily increasing during the manufacture, handling and storage of biologics.  Each contact component has the potential to introduce leachable compounds to the drug formulation.  The BioPhorum Operations Group (BPOG) has developed standardized extractables testing protocol for SUS.  This talk will review some of the central concepts of the BPOG protocol as well as current trends in performing extractable, leachable and simulation studies on manufacturing components and single use systems.