Cell and Gene Manufacturing and Logistics
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Deliver Potent Cell Therapies Faster, More Reliably And Enhance Cell Properties
10/8/2025
Accelerate the next generation of cell-based therapies with innovative technologies that streamline manufacturing, enhance scalability, and expand patient access worldwide.
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How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D.
10/7/2025
In Episode 113 of Cell & Gene: The Podcast, Host Erin Harris is joined by Thorsten Gorba, Ph.D., of Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing.
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Managing Cell Therapy Investigational New Drug (IND) Timeline Risks
10/7/2025
Managing timelines to IND is the top challenge in cell therapy, impacting funding, patent value, and patient access amid competitive, capital-constrained development environments.
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Key CMC Step For Cell Therapy IND Success
10/7/2025
Ensure cell therapy products are consistently manufactured with safety, quality, and potency, supporting regulatory approval and successful clinical development.
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How Strategic CMC Planning Drives Cell Therapy Success
10/7/2025
CMC is essential for cell therapy success, with FDA CRLs often due to CMC gaps; early strategic planning and robust controls reduce risks and accelerate market approvals.
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Regulatory Bar Raised For Cell Therapies: Are You Ready?
10/7/2025
Since 2024, multiple cell and gene therapy programs faced regulatory delays due to manufacturing deficiencies, highlighting the critical need for robust CMC strategies and inspection-ready operations.
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Cell & Gene Therapy Outsourcing's New Paradigm
10/7/2025
The industry has flipped from scarcity to surplus, and sponsors now have leverage to set terms, not take numbers.
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Redefining T Cell Culture Media
10/6/2025
Media selection is key to CAR-T cell success. Learn how a serum-free, xeno-free medium boosts transduction efficiency, maintains quality, and streamlines the path to clinical scale-up.
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Survey: 30% Of Biopharmas Cite Cost, Productivity As Top Priorities
10/6/2025
Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.
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Bringing CGT Home: Equipping Community Hospitals For The Next Frontier
10/6/2025
Decentralizing CGTs to community hospitals presents a crucial opportunity to improve patient access by reducing travel burdens, but requires overcoming significant challenges such as building specialized clinical infrastructure, coordinating complex care pathways, ensuring data interoperability, and more.