Point-of-care and decentralised cell manufacturing
Making CAR-T cells at or near the hospital instead of shipping cells to a central factory and back.
Academic centres (Sheba, Hospital Clínic Barcelona's ARI-0001, several Chinese and Indian programmes) and companies (Cellares 'Smart Factories', Orgenesis, Galapagos' decentralised model) manufacture cell therapies close to the patient, cutting vein-to-vein time to about a week and cost substantially. Regulators are working out how to license many small sites against one product specification.
How it works
Standardised closed platforms plus centralised quality oversight and digital batch records allow the same process to run at many sites.
- Days rather than weeks to product
- Lower cost
- Access for hospitals far from central plants
- Regulatory model immature outside a few jurisdictions
- Site-to-site comparability
- Vector supply still centralised
Latest papers
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