Mytos launches Automated CDMO for Manufacturing of Stem-Cell Derived Therapies

Mytos, a biotechnology company that automates cell manufacturing, announced the launch of its automated contract development and manufacturing organisation (CDMO) offering, designed to overcome one of regenerative medicine’s greatest bottlenecks: the scalable and affordable manufacturing of stem cell-derived therapies.

The first facility, located within the Cell and Gene Therapy Catapult’s (CGT Catapult) Stevenage Manufacturing Innovation Centre, aims to achieve 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.

“Regenerative medicine has extraordinary potential, but the cost and scalability of manual manufacture are barriers to reaching patients at scale,” said Ali Afshar, Ph.D., CEO and Co-Founder, Mytos. “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.”

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. 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.