Webinar: Strategies to Accelerate Gene Therapy Process Development from Preclinical to Manufacturing
Webinar Highlights (Live Q&A):
(1) A platform approach for early stage process development
(2) Efficient DoE application for process optimization and characterization
(3) Enhanced approach between PD and MFG for streamlined scale-up, tech transfer, and manufacture support
(4) Development of a new PAT tools application to better understand the process design space, therefore developing a control strategy
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Our About Our Speaker, Don Ornek, Ph.D:
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Date: Thursday, Jan 21st, 2021
Time: 2:00pm ET / 11:00am PT
Where: Your laptop or mobile device
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Abstract: Gene therapy is a fast-growing industry. Though demand for its products, including pDNA, AAV, retrovirus, lentivirus, and others, has significantly increased over the last 10 years, production challenges have remained unresolved. Gene therapy is a complex process with several unoptimized and low yielding steps. A typical process development (PD) cycle, from preclinical to manufacturing (MFG) takes 3 to 4 years. CuriRx has implemented the following strategies to accelerate process development, thereby enabling more rapid advancement of early clinical candidates to manufacturing:
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Don is the Senior Director, Process Development and Manufacturing at CuriRx, Inc. Dr. Ornek received his Ph.D. in Biochemical Engineering from Cornell University. He has more than 20 years of biotech industry experience in process development, process characterization, technology transfer, scaled up/down model validation, project management and operational excellence. The biologics that Dr. Ornek has worked on ranges from pre-clinical to commercial stages. Prior to CuriRx, Dr. Ornek served various positions at FujiFilm Diosynth, Lonza, and Genzyme.
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