Officials at Mytos, which is automating cell manufacturing, launched its automated contract development and manufacturing organization (CDMO), offering to overcome one of what they call regenerative medicine’s greatest bottlenecks: scalable, affordable manufacturing of stem cell-derived therapies.

The first facility, housed within the Cell and Gene Therapy Catapult’s (CGT Catapult) Stevenage Manufacturing Innovation Centre, is targeting clinical readiness by September 2026. Powered by Mytos’ iDEM™ automation technology, Mytos’ team at the site aim to be able to deliver up to 1,500 autologous doses or 25,000 allogeneic doses annually, with additional cleanroom space available to further multiply capacity.

This is the first of several planned global sites aimed at building the manufacturing backbone needed to bring regenerative medicines to millions of patients worldwide, according to Ali Afshar, PhD, CEO, and co-founder, Mytos.

“Regenerative medicine has extraordinary potential, but the cost and scalability of manual manufacture are barriers to reaching patients at scale,” said Afshar, adding: “With our automated iDEM-powered manufacturing sites, we’re addressing that challenge head-on. CGT Catapult’s expertise and status as a global cell and gene therapy innovation hub make this the ideal place to launch our first site and set a new standard for scaling regenerative medicines worldwide.”

Cost and complexity constrained the field

For years, the cost and complexity of manual manufacturing have constrained the field. Producing stem-cell derived therapies by hand is slow, expensive, and difficult to scale, dependent on scarce, highly trained operators, and vulnerable to variability as production scales. Building out capacity also requires major upfront capital investment and lengthy installation and qualification timelines.

Mytos’ automated CDMO provides a rapid and consistent path to scale, claimed Afshar, pointing out that the iDEM technology lowers the cost per dose, accelerates tech transfer by using the same flask format as manual culture, and gives developers immediate access to GMP capacity without the infrastructure costs or delays of traditional outsourcing.

Mytos selected the CGT Catapult’s Stevenage Manufacturing Innovation Centre as its launch site to leverage the organization’s expertise and track record. Over 200 patient batches have already released by companies at the site, and over 40 percent of these batches shipped to the U.S. CGT Catapult will collaborate with Mytos and continue to innovate, test, and validate manufacturing technology across GMP, supply chain, automation, and digitization, explained Afshar.

Importantly, CGT Catapult says it will support with de-risking Mytos’ transition to a CDMO, by helping the company integrate its technology first into a GMP-mirroring setting, before integrating into a GMP module.

“We are pleased to host Mytos’ first CDMO facility at our Manufacturing Innovation Centre,” said Matthew Durdy, CEO of the Cell and Gene Therapy Catapult.

“Mytos’ automation technology represents an important step forward in addressing the scalability and cost challenges of regenerative medicine manufacturing. By combining their innovative platform and manufacturing team with our innovation expertise and infrastructure, we can help accelerate the delivery of advanced therapies to patients around the world.”