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Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.
On Aug. 28, 2023, US-based Cellares, an integrated development and manufacturing organization (IDMO), announced that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program, a program that offers cell therapy developers opportunity to adopt Cellares’ automated manufacturing technology platform, the Cell Shuttle. Under the agreement, Bristol Myers Squibb will submit a proof-of-concept transfer process for the manufacture of one of its chimeric antigen T cell (CAR-T) cell therapies using the Cell Shuttle.
According to a company press release, Bristol Myers Squibb will use the program to evaluate Cellares’ automated manufacturing process and produce comparability data to confirm that the Cell Shuttle is a viable, cost-efficient, and scalable manufacturing solution for cell therapies. Through its TAP program, Cellares is working with cell therapy developers to implement its manufacturing platform as a clinical and commercial-stage good manufacturing practice (GMP) manufacturing solution at its IDMO smart factories.
The company’s technology platform can support both autologous and allogeneic cell therapy processes as well as approximately 90% of cell therapy modalities. According to the company press release, manual processes can be automated and tech-transferred onto Cellares’ automated Cell Shuttle platform in six months’ time using the TAP program. Under TAP, participating cell therapy developers can tech-transfer their cell therapy processes onto a Cell Shuttle at any stage, such as during pre-clinical development, or in the clinic, or after regulatory approval. Automation, standardization, and software-defined manufacturing combine to make any follow-up tech transfer thereafter instantaneous to any other Cell Shuttle in any other IDMO smart factory in any global location, according to the press release.
“We’re pleased to welcome Bristol Myers Squibb to the TAP program, and we look forward to demonstrating the ease and efficacy of transferring one of [the company’s] cell therapy process[es] onto the Cell Shuttle in the months to come,” said Fabian Gerlinghaus, CEO, Cellares, in the press release. “By combining integrated automation with a high-throughput platform, the Cell Shuttle offers unrivaled scalability for the cell therapy industry, while improving quality and lowering COGS [cost of goods sold].”
The launch of the IDMO and smart factories
The partnership with Bristol Myers Squibb follows on the heels of Cellares’ initial launch as an IDMO, the first of its kind dedicated to clinical and industrial-scale cell therapy manufacturing, according to an Aug. 23, 2023 company press release. At the time of its launch, Cellares had raised $255 million in Series C funding, which was led by US-based investment firm Koch Disruptive Technologies and in which Bristol Myers Squibb participated, along with others.
With this funding, Cellares launched a commercial-scale IDMO smart factory in Bridgewater, N.J., the first of its kind, according to the company press release. The 118,000-ft2 smart factory is designed to integrate advanced robotics, purpose-built technology, and interconnected software and will be capable of producing 40,000 cell therapy batches per year. The Bridgewater site will be GMP-ready in the second half of 2024. Under the integrated technologies, IDMO smart factories can produce 10 times more cell therapy batches per year than traditional contract development and manufacturing facilities and with the same footprint and workforce, according to the release.
Cellares currently operates two smart factories in the United States and is planning a third. Its first smart factory, located in San Francisco, Calif., is currently being used for preclinical process development and for the tech transfer of manual processes onto the company’s Cell Shuttle platform for existing partners. The San Francisco facility will be GMP-ready in early 2024, according to the company press release. Cellares intends to deploy its smart factories around the world to serve global patient demand for cell therapies and will break ground on the first IDMO smart factory in Europe in 2024.
“The creation of the first IDMO marks the beginning of a new era, in which cell therapies will finally be able to reach those in need,” said Gerlinghaus in the press release. “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.”