The Top Line
Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)
May 24, 2024
Bruce Levine, co-inventor of Kymriah, and industry experts discuss CAR-T therapies, infrastructure challenges, FDA warnings on T-cell cancers post-treatment, advancements in gene editing for heart patients, cost-effective manufacturing strategies, and G-Rex technology for optimized cell production.
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Quick takeaways
- Scalability of CAR-T therapies hindered by infrastructure challenges, necessitating improved access and development.
- Automation and decentralization in manufacturing promise enhanced efficiency, cost-effectiveness, accessibility, and therapy production capabilities.
Deep dives
Challenges in Cell and Gene Therapy Manufacturing
Cell and gene therapies such as CAR-T cells present unique challenges in manufacturing, which include complex processes like cell collection, manufacturing, quality control, and logistics management. The scalability and commercial accessibility of these therapies are affected by the need to train clinical and manufacturing sites, ensure quality control, handle logistics, and address insurance and reimbursement issues. Despite successes with over 35,000 patients treated globally, only 15-20% of eligible patients in the US receive CAR-T therapies, indicating the need for further infrastructure development and access improvement.
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