Automated cell therapy manufacturing pioneer Cellares has hit a key milestone, gaining a current Good Manufacturing Practice (cGMP) stamp of approval for its Cell Shuttle factory-in-a-box, which is the size of a truck and is designed to boost production while reducing costs and failure rates.
The platform has drawn a partnership with Bristol Myers Squibb and seven months ago the South San Francisco-based company attracted a $255 million series C funding round to complete construction of its commercial-scale manufacturing facility in Bridgewater, New Jersey.
The five-year-old startup, which dubs itself as the world’s first Integrated Development and Manufacturing Organization (IDMO), said that the release of its new version of its Cell Shuttle platform puts Cellares on track to gain readiness for production of clinical products by the end of this year.
In an arena in which the quality of production directly impacts patient outcomes, it's critical that cell therapies meet the highest standards of safety, efficacy, and consistency, Cellares noted in its release. Achieving cGMP compliance guarantees that the platform has been built and controlled to standards that meet strict regulatory requirements, assuring patient safety.
“The completion of our first cGMP-compliant Cell Shuttle instills confidence among healthcare providers, patients, and partners in the quality and reliability of the Cell Shuttle and signals our commitment to the highest standards of production,” Cellares CEO Fabian Gerlinghaus said in a statement.
While traditional cell therapy manufacturing has been hindered by its inability to scale effectively, Cellares says its end-to-end platform can reduce labor and facility size by 90%. With a comparable workforce and footprint, its automated setup can yield 10 times more cell therapy batches per year than a manual producer, Cellares said.
According to the company’s plan, the Cell Shuttles will be deployed in Cellares’ smart factories around the world to meet the growing demand for commercial production. A video, posted on the company's website, explains how the Cell Shuttle works.
Six months ago, BMS expanded its partnership with Cellares, signing on for a proof-of-concept manufacturing project for a second CAR-T product in its pipeline.