Extractable and Leachable Study Design For Disposables
11th February 2015 | 9PM ET / 2AM GMT / 3AM CET / 10AM SGT | Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables at Sanofi Pasteurand Jerry Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences |WATCH THIS FREE ON DEMAND WEBINAR
Ken Wong leads E/L support for all vaccine and biologic development programs and in-line supports at Swiftwater site of Sanofi Pasteur. He is also responsible for designing the site E/L guidance and strategy for container closure systems and disposable process components. He is a SME in the areas of extractable and leachable (E&L) study design, E&L compliance remediation planning, material change strategy development, risk ranking model design, and process contact materials (PCMs) (e.g., single-use system, hoses) qualification with over 14 years of Biopharma industry experience.
Mr. Wong is currently representing Sanofi on:
1) Extractable Standardization Subgroup within the Biophorum Operations Groups (BPOG),
2) ASME-BPE E&L subcommittee and
3) ELSIE material working group.
Mr. Wong also represent BPOG extractable standardisation group on USP expert panel committee.
Jerold Martin is Sr. Vice President, Global Scientific Affairs for Pall Life Sciences (division of Pall Corporation) and Chairman of the Bio-Process Systems Alliance (BPSA), the single-use bio-manufacturing trade association. He is an expert in bioprocessing, filtration and aseptic processing with over 35 years experience in the pharmaceutical and biotech industries, is a frequent speaker and author, including contributing to numerous PDA Technical Reports, BPSA Guides and ASTM, ISO and ASME-BPE Standards in the field. He has conducted technical seminars and trainings on filtration and single-use technologies for industry and regulatory agencies around the world, and in 2012, he was awarded the BioProcess Manufacturing Thought Leader of the Decade Award by BioProcess International Magazine for his efforts in promoting best practices for single-use manufacturing. He holds an M. Sc. in Microbiology from the University of Toronto.
Dr. James Hathcock, who is the Senior Director of Global Validation Chemistry at Pall Life Sciences, responsible for the extractables and leachables characterization of Biopharmaceutical products. Since joining Pall in 2008, James has been actively involved in chemical and performance characterization of Medical and Biopharmaceutical products, as well as relevant technical packages supporting FDA 510k filings. Prior to joining Pall, James was an assistant professor of hematology at the Mt. Sinai School of Medicine in New York City, where he served as director of a protein production and purification core laboratory. He is a member of the PDA and ASTM organizations
Sponsored by Pall Life Sciences
Pall Life Sciences develops, manufactures, sells and services products to customers that conduct research in the life sciences field, or in the production of therapeutic biologicals, drugs, vaccines and other biopharmaceuticals in-vitro diagnostic and healthcare markets.
Pall’s technologies are used from the earliest stages of new drug discovery and development to pilot and full-scale production; and then delivery of therapies for the prevention, diagnosis and treatment of diseases. Pall’s products and services help innovative drugs move faster to market and are used in laboratories, biotech applications, vaccine development, bioprocessing, fermentation, downstream processing, aseptic processing and sterile filling.
The Biopharmaceuticals group within Pall Life Sciences addresses the sub-market segments like biotechnology, vaccines, plasma, active pharmaceutical ingredients (API) and the formulation/filling. For each sub-market, Pall provides a broad range of advanced cell culture, filtration and separation solutions for each critical stage from drug development to production and provides validation services to assist drug manufacturers through the regulatory process and onto the market.