Cellares, an Integrated Development and Manufacturing Organization (IDMO), announced that its Cell Shuttle has received the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research (CBER). 

This designation acknowledges the Cell Shuttle’s ability to automate and reliably manufacture cell therapies and represents a significant step forward in the advanced manufacturing of cell therapies.

As a result of this designation, developers leveraging Cellares’ IDMO Manufacturing services will receive expedited FDA review, resulting in decreased times to IND and BLA, as well as a streamlined pathway to the approval of additional cell therapies leveraging the Cell Shuttle as a platform for their processes.

Cellares’ Cell Shuttle has performed automated, end-to-end, cell therapy manufacturing, including the processes of cell enrichment, cell selection, transduction, transfection, activation, expansion, and formulation while meeting all in-process and final product specifications of commercial cell therapies. 

Eric Fulmer, Vice President of Quality at Cellares. “By automating cell therapy manufacturing on the Cell Shuttle, our clients will have a streamlined and cost-effective pathway from clinical development to commercial manufacture, ultimately accelerating patient access to these critical therapies.”

With IDMO Smart Factories in development across the US, Europe, and Japan, Cellares offers clients global cell therapy manufacturing services to support early clinical development that also seamlessly scales to support industrial-scale manufacturing in the commercial setting, achieving economies of scale even at low production volumes.