The Cell & Gene Meeting on the Mesa is the sector’s leading annual conference bringing together top decision-makers in the industry to progress cutting-edge research into cures. This meeting will cover a wide range of topics from clinical trial design, to alternative payment models, to scale-up and supply chain platforms for advanced therapies. The program will feature expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 100+ dedicated presentations by leading publicly traded and privately held companies in the space.
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Moderator, Matthew M. Hewitt, B.A., Ph.D. Senior Director, Scientific Services, Cell and Gene Therapy
Challenges for developing a cell therapy product constantly evolve and shift, thus, reducing these risks requires expertise to navigate around them. From discovery, through late-phase clinical trials, to commercial manufacturing, various challenges and competing priorities are prevalent. Typical challenges include coordinating multiple CROs/CDMOs, effectively managing clinical operations, and overcoming supply chain and logistic hurdles, all while remaining in compliance with regulatory standards. This discussion will focus on how to bring your cell therapy product to market while mitigating risks, and reducing lag time.
On-Demand: Standardized Viral Vector & Plasmid Manufacturing and Analytics
Jeffrey Hung, PhD, General Manager, Vigene Biosciences, A Charles River Company
Scalability and affordability are two of the main prominent challenges for the viral vector gene therapy supply. To meet the need for increased viral vector manufacturing, we propose to establish standardized viral vector and plasmid manufacturing and analytics to ensure consistency of the productivity and to accelerate the release of GMP materials. Transfection efficiency, selection of producer cells, upstream production and downstream purification by chromatography as well as packaging plasmid manufacturing will be discussed. In addition, the newly launched AAV reference standards for AAV testing and analytics and their application for the standardized AAV testing will be overviewed.
• Viral vector GMP production process
On-Demand: High-Quality Cellular Starting Material to Support the Advancement of Cell Therapies
Jordan Hunter, Ph.D. Product Manager, GMP, HemaCare, A Charles River Company
The inherent variability of human-derived cellular starting material poses a significant commercialization challenge for cell and gene therapies. Therefore, early collaboration with a cellular supply provider is vital to support the efficacy of the therapy from the phases of early discovery, process development, and manufacturing. We discuss how effective donor recruitment and management in conjunction with consistent processing, cryopreservation, and logistics provide robust consistent starting material to support development of advanced therapies. Establishing an effective source supply partnership enables a seamless transition throughout the cell therapy continuum - from research use applications to GMP-compliant commercial manufacturing. Implementing these elements together mitigates product and process variability and improves the outcome of successful cell and gene therapies.