Decentralised Manufacturing

Point-of-care cell-therapy manufacturing brings personalised therapies closer to patients and reduces logistics complexity. The session covers hospital-based GMP closed systems (Lonza Cocoon, Miltenyi Prodigy), the regulatory considerations for distributed manufacturing under FDA Manufacturing Multiple Sites guidance, the comparison of centralised vs decentralised models, supply-chain economics of decentralised production, and the quality systems required at the point of care. Discussion addresses decentralised manufacturing in low- and middle-income countries, the role of academic medical centres in cell-therapy production, decentralised mRNA manufacturing platforms, the lessons from autologous CAR-T centralised supply chains, and emerging models for clinical-grade decentralised gene therapy.