Mytos Redefining How Regenerative Medicine is Made

As regenerative medicine continues to push the boundaries of modern healthcare, one challenge remains stubbornly persistent: manufacturing. The delicate, manual nature of stem-cell-derived therapy production has limited scalability, consistency, and affordability, slowing the transition from lab to clinic.

Mytos, a London-based biotech startup, is tackling this bottleneck head-on with its fully automated, closed manufacturing platform. At the heart of this innovation is the company’s proprietary iDEM™ automation technology, designed to bring precision, reproducibility, and industrial-scale efficiency to the cell therapy sector.

In this exclusive interview, MedTech Spectrum speaks with Ali Afshar, CEO and Co-Founder of Mytos, about how the company’s automated CDMO model is redefining how regenerative medicines are made — from accelerating tech transfer to lowering the cost per dose. Afshar also discusses Mytos’ partnership with CGT Catapult, its global expansion roadmap, and how automation could soon make advanced cell therapies accessible to patients worldwide.

Mytos’ automated CDMO offering aims to address the scalability and affordability challenges in regenerative medicine. What inspired the development of this solution, and how does it differentiate from traditional manual manufacturing?

The regenerative medicine field has advanced rapidly on the scientific front, but manufacturing has remained a major bottleneck. Most stem-cell-derived therapies are still produced manually—highly skilled scientists pipetting, feeding, and passaging cells by hand. That process is slow, expensive, and inherently variable.

Mytos was founded to change that. We set out to design a fully automated, closed system that can industrialize what has historically been a handcrafted process. Our platform integrates cell culture, monitoring, and analytics into a single automated workflow—bringing reproducibility, speed, and scalability that manual systems simply can’t achieve.

In short, we’re taking the same leap manufacturing went through in other industries—moving from artisanal to automated—so regenerative medicine can reach its full potential.

The first facility is powered by Mytos’ iDEM™ automation technology. Can you explain how this technology works and how it improves consistency, throughput, and quality in stem-cell-derived therapy production?

iDEM™ is the core of our automation engine—a modular, closed platform that performs the full cell culture process end-to-end, including expansion, differentiation, and harvest. It replaces manual touchpoints with precisely controlled, programmable steps while continuously monitoring key quality attributes such as media composition, cell morphology, and viability.

This continuous feedback loop ensures every cell batch experiences identical growth conditions, resulting in improved reproducibility and yield. iDEM™ also runs around the clock, maximizing throughput without increasing labor costs. The combination of precision automation and real-time analytics drives both process control and product quality far beyond what manual workflows can achieve.

Manual manufacturing has long been a bottleneck in regenerative medicine. How does automation lower the cost per dose and accelerate tech transfer for developers?

Manual manufacturing is labor-intensive and doesn’t scale easily. Each batch depends on highly trained operators, which introduces variability and drives cost. Automation eliminates those limitations.

With iDEM™, one automated system can perform the work of several operators continuously and with greater precision. That directly lowers the cost per dose. The platform’s digital nature also means that once a process is validated, it can be replicated anywhere in the world—turning what used to be a year-long tech transfer process into a software deployment.

This allows therapy developers to scale faster, expand globally, and reach patients sooner—all while maintaining consistent quality.

Your first site is located within CGT Catapult’s Stevenage Manufacturing Innovation Centre. How does this partnership contribute to operational efficiency, regulatory compliance, and scaling capacity globally?

The CGT Catapult is one of Europe’s leading centres for advanced therapy manufacturing, and locating within its Stevenage facility gives us immediate access to GMP-aligned infrastructure, regulatory guidance, and collaboration opportunities.

By co-locating at Catapult, we’re able to accelerate process validation, align with regulatory expectations early, and leverage their experience in scaling cell and gene therapy manufacturing. The partnership also situates Mytos in a thriving innovation ecosystem—enabling collaboration with therapy developers and creating a replicable model we can export to other regions.

This first site is not just a facility—it’s a global template for automated, scalable, compliant manufacturing.

Looking ahead, what is Mytos’ strategy for expanding automated manufacturing globally, and how will you ensure these facilities meet the growing demand for regenerative therapies?

Our strategy is to build a distributed network of automated manufacturing hubs powered by the iDEM™ platform. Each site will share the same standardized, digital architecture—ensuring that processes are harmonized and fully traceable across geographies.

Following our UK launch, we plan to expand into North America and Asia to meet global demand. By maintaining digital and GMP alignment across facilities, we can scale rapidly while guaranteeing product consistency and regulatory readiness.

The ultimate goal is to make high-quality, stem-cell-derived therapies accessible to patients worldwide by transforming how they’re manufactured.

How do you see automation transforming the broader regenerative medicine and cell therapy industry over the next 3–5 years, particularly in terms of patient access and treatment affordability?

Over the next few years, automation will shift regenerative medicine from bespoke science to scalable industry. We’ll see cell therapies that once cost hundreds of thousands of dollars per patient become far more affordable, thanks to continuous, high-throughput manufacturing.

Automation will also enable global availability—standardized processes that can be deployed across regions without compromising quality. This transformation will expand patient access, reduce production timelines, and create the foundation for truly industrialized regenerative medicine.

At Mytos, we believe automation isn’t just about efficiency—it’s about unlocking access. Our vision is a world where advanced cell therapies can be manufactured as reliably and affordably as any modern biologic drug.