Decentralized Manufacturing remains a hot topic in the Cell and Gene Therapy industry. After chairing a panel of industry experts for Advanced Therapies Week in a discussion on how decentralization could potentially revolutionize the manufacturing approach for cell and gene therapies, I bring to you 5 key takeaways from the session.
Special thanks to the panelists for your insights: Lee Buckler, Ian Gaudet, and Marcos De Lima.
1. Decentralized manufacturing means:
- Manufacturing closer to the patients, closer to the clinical sites, which keeps the patient closer to home for collection and infusion.
- Not necessarily manufacturing at the point-of-care.
- Not manufacturing in big palaces of clean rooms.
2. Patient perspectives:
- Huge unmet demand to treat eligible patients.
- Prohibitive cost to the therapy.
- In some cases, therapies are not being prescribed, indicating a need for patient and physician education.
3. Trends with tools include:
- Miniaturize, integrate and functionally close the tools and technologies.
- Simplify and automate tools and technologies.
- Digitizing every step of the vein-to-vein workflow.
4. The regulatory pathway is evolving:
- Moving away from paper forms and QMS to digitalization.
- Realtime manufacturing process analytics.
- Centralized oversight of decentralized manufacturing by FDA audited facility.
5. What is required for adoption like this is:
- Technology readiness for decentralized manufacturing.
- Onsite analytics with rapid turn around time for product release.
- Continued FDA approval of shortened and simplified processing solutions for decentralized manufacturing.
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