Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA

Title

"FDA Awards Cellares’ Cell Shuttle Advanced Manufacturing Technology Designation for Automated Cell Therapy Production"

Keywords

• Cellares
• Cell Shuttle
• FDA
• Advanced Manufacturing Technology (AMT)
• Cell therapy manufacturing
• Automation
• IDMO Smart Factory
• Biologics License Application (BLA)
• Investigational New Drug (IND)
• CAR T-cell therapy

Key Facts

1. FDA Designation:
The U.S. Food and Drug Administration (FDA) granted the Advanced Manufacturing Technology (AMT) designation to Cellares' fully automated cell therapy manufacturing platform, the Cell Shuttle12.

2. Benefits of AMT Status:
Companies using the Cell Shuttle receive priority FDA reviews, accelerating regulatory filings such as Investigational New Drug (IND) and Biologics License Applications (BLA), thereby shortening development and approval timelines125.

3. Capacity and Efficiency:
The Cell Shuttle platform automates the entire cell therapy manufacturing process, achieving a 90% reduction in manual labor, cutting batch costs by up to 50%, and enabling concurrent production of therapies for 16 patients57.

4. Scalability:
Cellares employs its Cell Shuttle in IDMO Smart Factories worldwide. Its facility in Bridgewater, New Jersey, can manufacture up to 40,000 CAR T-cell therapy doses annually, and global scaling plans include factories in Europe and Japan125.

5. Unique Technology:
The Cell Shuttle integrates end-to-end automation, including cell enrichment, transduction, expansion, and formulation, ensuring consistent and scalable production of high-quality cell therapies28.

6. Partnering Pharma Companies:
Big Pharma clients like Bristol Myers Squibb and Gilead’s Kite, as well as smaller biotech firms, utilize the Cell Shuttle for faster and more reliable cell therapy production15.

7. Impact on Cell Therapy Market:
The AMT designation affirms Cellares’ Quality-by-Design approach as a transformative solution in the cell therapy manufacturing industry, promoting cost-efficiency and broader patient access to innovative therapies25.

Sources:

1. https://www.pharmamanufacturing.com/industry-news/news/55278812/cellares-secures-fda-advanced-manufacturing-technology-designation-for-its-cell-shuttle

2. https://www.cellares.com/news/cellares-cell-shuttle-receives-fda-advanced-manufacturing-technology-amt-designation-for-automated-cell-therapy-manufacturing/

5. https://njbiz.com/fda-awards-cellares-first-of-its-kind-designation/

7. https://www.bioprocessintl.com/regulations/cellares-cell-shuttle-secures-amt-designation-by-the-us-fda

8. https://pharmasource.global/content/news/cdmo-news/cellares-secures-fda-amt-designation-for-cell-shuttle-in-cell-therapy-manufacturing/