Application of USP 665 data to support qualification of single use systems

This talk will focus on an overall application of USP <665> starting from risk assessment to qualification of disposable manufacturing systems based on the USP<665> data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP<665> data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide a broader understanding.
Presented by Ken Wong, Deputy Director at Sanofi Pasteur

Ken Wong is a Deputy Director of Process Technology Platform at Sanofi Pasteur. Serving as the Swiftwater site extractables and leachables (E&L) SME but also provide E&L supports to all global sites. His 19-year in biopharma professional career has ranged from R&D to development and commercialization to cGMP manufacturing support. For the last 17 years, he has specialized in E&L in wide range of packaging systems (including lyophilized powders, oral liquids, creams, ophthalmic solutions, transdermal, bio-surgical delivery systems, injectable devices, and inhalation devices for aerosol, solutions and powders). In the last 10 years, he has been heavily involved with Single-Use Technology and actively participating in Disposable workstreams of BioPhorum Operations Group (BPOG), the USP <665> Expert Panel and the ELSIE material working group.
Followed by USP <665> Standardized Extraction Solution Protocol for Manufacturing Components and Systems
Presented by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia

Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA.
Followed by Life After Extractables Standardization
Now five years past the publication of the 2014 Biophorum extractables protocol, a second version of the protocol is on the horizon as well as a 4th draft of USP <665>. This presentation highlights the top issues influencing the alignment of the Biophorum and USP <665> protocols, the expected resolution, and the key opportunities ahead for continuing to simplify the adoption of single-use, while continuing to innovate with new materials associated with sensors, continuous bioprocess, and gene therapy.
Presented by James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech


James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for E&L characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA, Biophorum-supplier phorum as well a USP <665> expert panel member. Since joining Pall in 2008, James has led chemical and performance characterization of medical and biotech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.
Sponsored by Pall Biotech

Pall Biotech offers a blend of innovative traditional, single-use and continuous processing technologies and services to create scalable bioprocessing solutions that are flexible to each type of manufacturer’s process. From concept through to design, validation and production, our team leverages best-in class technologies with industry-leading support for all bioprocessing applications. Whether that means fast-tracking a new drug, helping to ensure regulatory compliance, or making existing processes easier, faster and better, we are ready to fulfill your unique needs. Want to learn more about how Pall Biotech can enhance your bioprocesses from start to finish?
 
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