Cellares and Cabaletta Bio announced Wednesday the successful completion of the manufacturing Technology Adoption Program (TAP) using the Cell Shuttle platform.

NJBIZ has reported extensively about Cellares, which operates its first commercial-scale Integrated Development and Manufacturing Organization (IDMO) Smart Factory in Bridgewater.

The program examined the ability of Cellares‘ IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio’s clinical-stage drug, rese-cel, a CD-19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases.

And it delivered.

On a single Cell Shuttle, the TAP successfully produced automated, concurrent manufacture of multiple rese-cel batches. The companies say this successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship.

Next-gen automation

“The success of this Technology Adoption Program demonstrates the effectiveness of the Cell Shuttle as a scalable, automated, and cost-effective platform for the manufacturing of cell therapies,” said Cellares CEO Fabian Gerlinghaus in a March 19 press release. “Working with Cabaletta Bio proves that small biotech companies can successfully partner with Cellares to benefit from next-generation automation.”

“Through our partnership with Cellares, our teams have successfully achieved proof of concept for the ability to automate the rese-cel cellular drug substance manufacturing process,” said Gwendolyn Binder, president, Science and Technology, at Cabaletta Bio. “I believe that the potential increase in capacity, meaningful reduction in costs, and rapid global technology transfer offers a potential solution for the global scale out of rese-cel for patients with autoimmune disease.”

Key points of the collaboration include:

• The Cellares network of global IDMO Smart Factories planned for the U.S., Europe and Japan has the potential to provide Cabaletta with the ability to automate, lower costs and scale out manufacturing
• May facilitate the global expansion of rese-cel via rapid technology transfer to additional IDMO Smart Factories
• Has potential to allow Cabaletta Bioto reach the global scale required to meet the total patient demand across multiple autoimmune diseases – including myositis (approximately 70,000 U.S. patients), scleroderma (about 90,000 U.S. patients) and lupus (nearly 100,000 U.S. patients) – in a fraction of the time and initial investment it would usually take to develop and deliver global supply to these large patient populations
• Cell Shuttle performed all unit operations in an automated manner – with the process delivering drug products that met pre-defined quality ranges

Speeding production, cutting costs

Cellares notes that the Smart Factories allow clients to effectively realize economies of scale even at the low batch numbers required by clients in early clinical development. The spaces provide the the ability to manufacture 10 times the number of therapies in a small space – for half the cost. The Bridgewater facility uses robotics and other automation to optimize the processes. Cabaletta marks the first announced company to complete this proof-of-concept stage, now preparing into clinical scale-up.

“We are excited to contribute to the advancement of rese-cel and the delivery of life-changing therapies to patients worldwide,” said Gerlinghaus.

Binder added, “We look forward to continuing our work together to complete activities required to enable the use of the Cell Shuttle in clinical trials to support the delivery of these potentially curative autologous therapies to more patients with autoimmune diseases.”