Mytos launches automated CDMO to scale regenerative medicine manufacturing
Mytos, a biotechnology company specializing in automated cell manufacturing, announced it has launched an automated contract development and manufacturing organization (CDMO) for scalable and affordable stem cell–derived therapy production.
The company’s first site, housed within the Cell and Gene Therapy Catapult’s (CGT Catapult) Stevenage Manufacturing Innovation Center in the UK, is expected to achieve clinical readiness by September 2026. Powered by Mytos’ iDEM automation platform, the facility will reportedly target annual production of up to 1,500 autologous or 25,000 allogeneic doses, with additional cleanroom space available to expand capacity.
“Regenerative medicine has extraordinary potential, but the cost and scalability of manual manufacture are barriers to reaching patients at scale,” Ali Afshar, CEO and co-founder of Mytos, said in a statement. “With our automated iDEM-powered manufacturing sites, we’re addressing that challenge head-on.”
Mytos’ automated system reportedly lowers per-dose costs and accelerates technology transfer by maintaining compatibility with manual culture formats. The company said its CDMO model provides developers with immediate GMP-ready capacity while eliminating traditional infrastructure costs and long setup timelines.
CGT Catapult, a UK government-supported innovation hub, will collaborate with Mytos to test, validate and integrate the company’s manufacturing technology across GMP, automation and digital systems.
“Mytos’ automation technology represents an important step forward in addressing the scalability and cost challenges of regenerative medicine manufacturing,” CGT Catapult CEO Matthew Durdy said in a statement.
To support its CDMO expansion, Mytos has added several industry veterans to its leadership team, including David DiGiusto, former CTO of Semma Therapeutics and Resilience, as an advisor; Barry Oliver, former VP of Global Cell & Gene Therapy Quality at Catalent, as interim head of quality; and Felix Quagiarello, former director of business development at Cellares, as senior director of business development.