Leveraging Current Technology And Regulatory Frameworks To Deliver Patient Access Today

The pharmaceutical industry is shifting towards decentralized manufacturing models in order to improve patient access to life-changing therapies. Regulatory bodies like the FDA and MHRA have provided guidelines on different manufacturing models. The FDA has defined four types of manufacturing models: centralized, distributed, decentralized, and point-of-care. The EU has also published updates on regulating decentralized manufacturing. Infrastructure is a crucial factor in improving patient access to cell and gene therapies, and there have been delays in their launch. Hospital-based therapeutics, particularly CAR-Ts, are emerging as an approach to improve patient access, but questions around reimbursement and widespread adoption remain.

Overcoming bottlenecks such as quality oversight, comparability between sites, and technology innovation is necessary to make decentralized manufacturing a reality. The existing technology and infrastructure are sufficient to deliver high-quality decentralized manufacturing. The partnership between Title21 and Germfree aims to integrate modular and mobile cleanroom facilities with adaptable software solutions to create a unified system for multiple manufacturing sites. This approach allows for standardized processes, remote monitoring, and control, and centralized quality oversight. Innovation and collaboration are needed to improve affordability and patient access to cell and gene therapies.