Cellares secures FDA Advanced Manufacturing Technology designation for its Cell Shuttle

San Francisco-based Cellares announced that its automated cell therapy manufacturing Cell Shuttle platform has been granted the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research.

Cellares said that the AMT designation gives its customers using the Cell Shuttle priority review from the FDA, leading to accelerated regulatory filings and resulting in decreased times to Investigational New Drug (IND) and Biologic License Application (BLA).

“Cell therapy developers working with Cellares now receive prioritized FDA review of their applications — that has the potential to shorten development timelines, get a response to INDs and BLAs faster, and make these therapies available to more patients faster,” Fabian Gerlinghaus, co-founder and CEO of Cellares, told Pharma Manufacturing. 

While other technology companies are developing automated cell therapy manufacturing, Gerlinghaus contends that “they are not automating to the same extent” as Cellares which has automated “the entire process from start to finish” with a much higher throughput running 16-patient doses simultaneously compared to only a single patient dose.

Cellares is deploying its Cell Shuttle at the company’s integrated development and manufacturing organization (IDMO) “smart” factories. The first commercial scale smart factory is operational in Bridgewater, New Jersey, with other facilities under construction in Europe and Japan.

The Bridgewater site will be capable of producing up to 40,000 standard CAR T-cell therapy doses annually, or up to 100,000 doses of novel, two-day process CAR T-cell therapies. The facility has the capacity to accommodate 38 Cell Shuttles, while the sites in Europe and Japan will each house 48 Cell Shuttles. When all three facilities are up and running, Cellares estimates that it will produce up to 380,000 patient doses per year.       

Gerlinghaus noted that while the speed of regulatory review is critical for pharmaceutical companies, it’s particularly important for biotech companies. Among Cellares’ customers are five Big Pharma companies — two of which, Bristol Myers Squibb and Gilead’s Kite, have been publicly disclosed — as well as smaller biotech companies such as Caballeta Bio and Lyell Immunopharma.

Last month, Cellares announced that it successfully completed a Technology Adoption Program (TAP) using its Cell Shuttle for Cabaletta Bio’s lead clinical candidate rese-cel, a CAR T-cell therapy designed to treat patients with a broad range of autoimmune diseases.

The TAP program demonstrated the ability of Cellares’ IDMO Smart Factory to “automate, lower costs and scale out manufacturing for Cabaletta Bio’s clinical-stage CAR T program to treat patients with autoimmune diseases,” according to the announcement.

Having successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle, the two companies are working towards the goal of manufacturing cGMP cell therapy batches to be delivered to patients.