Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)
May 24, 2024
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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.
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.
Strategic Decisions in Therapy Development
Early decisions in therapy development impact scalability and manufacturing challenges. Companies like Cell Prothera faced resistance in concurrently developing clinical and manufacturing processes due to investor focus on clinical aspects over manufacturing. The focus on solid tumors poses challenges due to antigen choice, access issues, and complex tumor microenvironments complicating therapy access and manufacturing. Developing fully automated closed systems could revolutionize decentralized production and enhance treatment access.
Technical Advancements and Automation in Manufacturing
Advancements in automation and decentralized manufacturing are reshaping cell and gene therapy production. Implementing automation requires a simplified and optimized manufacturing process to avoid scalability and cost complexities. Automation enhances consistency and efficiency in production, especially with reduced material costs and optimized cellular oxygenation in technologies like G-Rex. Engaging early with technology vendors facilitates efficient manufacturing and process scalability, benefiting the therapy's commercial deployment.
Promising Future of Cell and Gene Therapies
The future of cell and gene therapies holds potential for wide-reaching impact and improved patient outcomes. Adoption of scalable and standardized manufacturing platforms like G-Rex sets the stage for cost-effective and efficient therapy production. Innovations like CRISPR approvals provide avenues for permanent cures, addressing challenges in scalability, accessibility, and remediating regulatory concerns. Collaborations between technology providers, developers, and regulatory bodies pave the way for advancing therapeutic accessibility and efficacy.
This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing.
In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera.
They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies.