Phacilitate Leaders World & World Stem Cell Summit

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OrganaBio’s mission is to democratize access to mission-critical, hard to procure, resources that companies need for growth. One such resource is immediately-available GMP manufacturing space. The democratization of immediately-available GMP space would be an unparalleled solution to a critical industry bottleneck. Companies would gain business agility and reduce startup timelines and costs, accelerating the innovation cycle of cell and gene therapies. We are currently building a multi-tenant manufacturing facility to provide companies with the option to rent GMP space and manufacture their products with total control, with only the support services they desire. Each ISO 7 GMP suite within our facility is engineered for maximum seclusion from outside spaces and to accommodate tissues, cells, viruses and other raw materials typically utilized in cell and gene therapy manufacturing processes. To increase manufacturing flexibility, we have designed our pods in a modular fashion to accommodate process changes, specialty equipment and/or multiple processes/unit operations. Finally, to support all aspects of manufacturing operations and product manufacture, testing and release, and to defray overhead and operational costs, tenants will have access to shared resources, OrganaBio subject matter experts in GMP operations, facilities, process development, Regulatory Affairs, and Quality Control (QC), and core QC space and equipment. This novel option presents the industry with a rapid path to manufacturing with no capital expenditure, while retaining total control over one’s process and product, establishing a new paradigm in cell and gene therapy manufacturing.
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