Utility of Generating <665> Data: Drug Manufacture’s Perspective: Will USP permit such format?


23rd June 2020 | 10.00 am EST | Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia |BOOK FREE SEAT

This talk will focus on an overall application of USP <665> starting from risk assessment to qualification of disposable manufacturing systems based on 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 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.

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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