Point-Of-Care Manufacturing vs. Decentralized Manufacturing In Cell & Gene Therapies

By Stephen Ondek, Customer-Focused Cleanroom Professional

Point-of-Care (PoC) and Decentralized Manufacturing are the two most prominent production models used in cell and gene therapies. PoC Manufacturing involves producing therapies on-site, enhancing the speed and personalization of treatment delivery by producing therapies where patients receive treatment. However, this requires a significant investment in specialized equipment, training, and regulatory compliance. On the other hand, Decentralized Manufacturing increases accessibility and scalability by spreading production across multiple units in different locations, with its own challenges of robust coordination, quality control, and resource allocation. The specific needs and capabilities of your organization, along with the patient population, can help determine which of these two models will best suit your needs.