Article | July 24, 2024

Decentralized Manufacturing And The Accessibility Of Cell & Gene Therapies

Source: ProPharma
GettyImages-1026858958 manufacturing worker

Cell and gene therapies hold tremendous promise in revolutionizing healthcare by offering potential cures for a wide range of diseases. However, their broad-scale adoption has been hampered by numerous development and operational challenges.

ProPharma’s decentralization solution aims to overcome these barriers by establishing less costly, fully functional, and licensed (FACT) point-of-care facilities capable of delivering cell-based therapies locally. The high complexity of cell and gene therapy manufacturing necessitates significant process control, demanding logistics (cold chain), subject knowledge, and careful decision-making, all of which have driven the current resource- and cost-intensive centralized model.

Even with proven safety and efficacy, providers must address significant regulatory hurdles, including treatment application, appropriate reporting, follow-up, and signal identification; GxP requirements, product release specifications, and assurance that the treatment meets regulatory standards; raw material logistics, scalable manufacturing, and reimbursement management; and post-treatment monitoring.

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