Cellares, an integrated development and manufacturing organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, has secured $255 million in Series C funding led by new investor Koch Disruptive Technologies.

In a statement, Cellares explained that the new funding will be used to launch the world’s first commercial-scale IDMO smart factory, which seamlessly integrates advanced robotics, purpose-built technology, and interconnected software.

The 118,000 sq. ft. IDMO Smart Factory, located in Bridgewater, New Jersey, will be capable of producing 40,000 cell therapy batches per year. By leveraging integrated technologies, IDMO Smart Factories can produce 10 times more cell therapy batches per year than traditional CDMO facilities, even with the same footprint and the same workforce. Cellares’ Smart Factories will be deployed around the world to enable the cell therapy industry to meet global patient demand.

The company’s flexible manufacturing technology supports both autologous and allogeneic cell therapy processes and about 90% of cell therapy modalities. The Cell Shuttle platform integrates all the technologies required for all unit operations and is successfully running CAR-T cell therapy processes with true walk-away, end-to-end automation. Compact automation leads to a 90% reduction in labor and facility size to produce the same number of batches, thus enabling the 10x increase in productivity of Cellares’ IDMO Smart Factories.

Cellares currently operates two Smart Factories in the US and is planning a third. Cellares’ first Smart Factory, located in South San Francisco, is currently being used for preclinical process development and tech transfer of manual processes onto the Cell Shuttle for existing partners. The South San Francisco Smart Factory will be cGMP-ready in the first half of 2024.

The new Smart Factory in Bridgewater is dedicated to commercial-scale manufacturing. With 118,000 sq. ft. of space, the site has capacity for 50 cell shuttles and will be able to produce 40,000 batches per year. The New Jersey site will be cGMP-ready in the second half of 2024. While the company can support clinical trials in Europe out of its US Smart Factories, it will also break ground on the first IDMO Smart Factory in Europe in 2024.

Manual processes can be automated and tech transferred onto Cellares’ automated Cell Shuttle platform in only six months via the company’s Technology Adoption Partnership (TAP) program. Under the TAP program, participating cell therapy developers can tech-transfer their cell therapy processes onto a cell shuttle at any stage – during pre-clinical development, in the clinic, or after regulatory approval.

“Cell therapies have tremendous curative potential across a wide range of diseases,” said David Mauney, managing director of Koch Disruptive Technologies. “But right now, manufacturing by conventional CDMOs is expensive, failure-prone, and impossible to scale. Cellares is driving transformation in the marketplace by combining an Industry 4.0 approach with full vertical integration. As the first IDMO, Cellares is empowering cell therapy companies to build viable businesses, remain competitive, and meet the needs of fast-growing patient populations.”

“The creation of the first IDMO marks the beginning of a new era, in which cell therapies will finally be able to reach patients in need,” said Cellares CEO Fabian Gerlinghaus. “We’ve developed integrated technologies for the entire drug development and manufacturing life cycle. Now we’re leveraging these technologies to offer global manufacturing services for the living drugs of the 21st century. Our partners are some of the best academics, biotechs, and large pharma companies in the world. We’re enabling them to meet total patient demand, improve consistency and quality, lower manufacturing costs, and accelerate expansion to new markets.”