Scaling Regenerative Medicine: Mytos Launches Its First Automated CDMO
Regenerative therapies are delivering real clinical results—reversing Parkinson’s symptoms, restoring vision, repairing bone, and more—yet most remain limited by manual manufacturing. Growing cells by hand is slow, variable, labor-intensive, and expensive, with per-dose costs often reaching hundreds of thousands of dollars. Building conventional capacity takes years and major capital. The science can work; production frequently cannot keep pace.
Mytos is addressing that bottleneck. The company has launched an automated CDMO, with its first facility at the Cell and Gene Therapy Catapult’s Stevenage Manufacturing Innovation Centre. Powered by its iDEM™ platform, the site targets clinical readiness by September 2026 and is designed for up to 1,500 autologous or 25,000 allogeneic doses annually, with room to expand. It is the first of several planned global sites. (Full announcement)
iDEM automates the full cell-culture workflow—coating, seeding, feeding, imaging, passaging, and harvesting—while using the same standard T-flask formats as manual processes. This shortens technology transfer, preserves the underlying biology, lowers cost per dose, and reduces labor and cleanroom footprint, giving developers faster access to GMP capacity without multi-year facility builds. The Catapult site adds proven GMP expertise (more than 200 patient batches released, a substantial share shipped to the US). Mytos has also added experienced operators, including David DiGiusto (former CTO of Resilience and Semma) as an advisor.
The move builds on years of platform refinement and collaborations with teams advancing therapies for Parkinson’s, vision, hearing, and bone repair. From an investor perspective, it is a logical step: a technology that solves a hard problem creates lasting value when it becomes reliable production capacity customers can actually use. By operating automated sites, Mytos is positioning itself to help turn clinically promising regenerative therapies into medicines that can be made at the volumes and costs needed to reach patients.