Cellares Secures FDA AMT Designation for Cell Shuttle in Cell Therapy Manufacturing

• Cellares’ Cell Shuttle has received the FDA’s Advanced Manufacturing Technology (AMT) designation, recognising its automation capabilities in cell therapy manufacturing.

• The designation offers therapy developers expedited regulatory review, potentially reducing time to IND and BLA approvals.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has announced that its Cell Shuttle has been granted the Advanced Manufacturing Technology (AMT) designation by the U.S. Food and Drug Administration (FDA). The designation, issued by the Center for Biologics Evaluation and Research (CBER), recognises the system’s ability to automate and streamline cell therapy manufacturing.

The AMT designation is designed to encourage the use of innovative technologies that improve the efficiency, quality, and scalability of advanced therapies. For developers utilising Cellares’ IDMO Manufacturing services, the designation enables an expedited FDA review process, potentially reducing the time required for Investigational New Drug (IND) and Biologics License Application (BLA) approvals.

“The AMT designation for our Cell Shuttle is a testament to its potential to transform patient outcomes by delivering scalable and cost-effective cell therapy manufacturing,” said Fabian Gerlinghaus, CEO and co-founder of Cellares. “This designation now gives cell therapy developers leveraging Cellares IDMO manufacturing services prioritised FDA review, which has the potential to shorten development times, making these therapies available to more patients faster.”

The Cell Shuttle automates the entire cell therapy manufacturing process, including cell enrichment, selection, transduction, transfection, activation, expansion, and formulation. The system has met all in-process and final product specifications for commercial cell therapies, reinforcing its ability to produce high-quality therapeutic products at scale.