Cellares Set to Launch Good Manufacturing Practice–Compliant Cell Shuttle Manufacturing Platform

Cellares, a self-titled integrated development and manufacturing organization (IDMO), has announced that it has completed its first current Good Manufacturing Practice (cGMP)–compliant Cell Shuttle, an automated cell therapy manufacturing platform that can purportedly significantly reduce costs and process failures associated with the production of cell therapies.

The Cell Shuttle’s adherence to cGMP qualifies that it has been built to strict regulatory guidelines, with patient safety in mind. “By adhering to cGMP standards, Cellares ensures that cell therapies produced on the Cell Shuttle are safe, effective, and are consistently of the highest quality which is critical for patient care and therapeutic outcomes,” stated Fabian Gerlinghaus, CEO of Cellares, in a press release.

Challenges to the cell therapy sphere include high costs, high process failure rates, and an inability for manual manufacturing processes to scale effectively. Cellares hopes to address these issues with the Cell Shuttle, which is designed to cut down on labor and facility space requirements by 90%. Because of this, Cellares states that its IDMO Smart Factories can produce ten times the cell therapy batches per year as conventional CDMO facilities, with the same workforce and footprint.

In an interview with Pharmaceutical Technology, Fabian Gerlinghaus, chief executive officer and co-founder of Cellares, spoke on the catalyst that drove Cellares’ creation. “I was attending a lot of cell therapy conferences. And if you listened, people were shouting from the rooftops, we need closed highly automated, reliable cell-type manufacturing technologies in order for this industry to be viable in the long term, and in order for us to meet the patient demand. It is outrageous that there are patients dying on the waitlist, even though they're eligible for FDA-approved cell therapies on the market because the industry can't meet demand,” Gerlinghaus said. “[In 2018], I was walking around on the exhibition floors of the typical cell therapy conferences… and there was just nothing on the market that I thought would actually be able to solve the scalability and the cost and the quality problems. And at that point, Omar and I teamed up to start Cellares, and build a technology platform that actually does solve all three of these issues.”

With the completion of the cGMP-compliant Cell Shuttle, Cellares draws closer to making that goal a reality. The company is preparing to rapidly advance their manufacturing capabilities, recently adding a commercial-scale IDMO Smart Factory, located in Bridgewater, New Jersey, to its existing facility in San Francisco.

Watch part one of Pharmaceutical Technology's interview with Gerlinghaus to learn more about Cellares and the capabilities of its Cell Shuttle platform.

Source: Cellares