Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production

23rd March 2020 | 10.00 am EST | Ping Wang, Director at Johnson & Johnson and Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services |WATCH FOR FREE

  • Safety assessment of extractables and leachables is often based on the 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, Ph.D,  Director at Janssen, Malvern, Pennsylvania

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.

Followed by Current Trends in Extractables and Leachables Testing from Manufacturing Equipment to Single Use Manufacturing Components

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.

Presented by Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services

Dr. DeCou is the Extractable and Leachables Technology Manager at West Pharmaceutical Services.  His primary responsibility is to develop and increase knowledge of industry & technology as it applies to extractables and leachables and to effectively support West in identifying and growing future analytical expertise.  Don has been working in the pharmaceutical industry for over 20 years with increasing responsibilities relating to extractables and leachables in roles ranging from analyst, supervisor, subject matter expert, and manager. He has worked for companies such as 3M (in their Pharmaceuticals /Drug Delivery Systems divisions), PPD, Covance, Alcami, and Pace Analytical.  He received his Ph.D. in Analytical Chemistry from Kansas State University in 1993.

Sponsored by West Pharmaceutical Services, Inc.

An integral part of the healthcare industry, West’s top priority is delivering quality products that meet the product specifications and quality standards customers require and expect. This focus on quality includes excellence in manufacturing, as well as scientific and technical expertise. At the manufacturing level, this means producing clean, sterile, high-quality components to help minimize disruptions to the supply chain and bring safe, effective drug products to the market—and to the patient—quickly and efficiently.

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