Cellares' Cell Shuttle Receives Advanced Manufacturing Technology Designation from FDA
04/02/25, 8:47 PM
Location
Industry
biotechnology
manufacturing
Type
agreement
Cellares' Cell Shuttle, an automated cell therapy production platform, has been awarded the coveted advanced manufacturing technology (AMT) designation from the FDA's Center for Biologics Evaluation and Research. This designation is expected to enhance the adoption of innovative technologies and improve the efficiency, quality, and scalability of cell therapies.
Company Info
Location
345 allerton ave
san francisco, california, united states
Additional Info
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.