Mytos Launches Automated CDMO to Scale Stem Cell Therapy Manufacturing
核心洞察
Mytos (搜索) has launched its first automated contract development and manufacturing organization (CDMO) facility within the Cell and Gene Therapy Catapult's Stevenage Manufacturing Innovation Centre, targeting clinical readiness by September 2026.
The facility, powered by Mytos (搜索)' iDEM™ automation technology, aims to deliver up to 1,500 autologous doses or 25,000 allogeneic doses annually, addressing scalability and cost barriers in regenerative medicine manufacturing.
The company has secured partnerships with three biotechnology companies including StemSight (搜索), Rinri Therapeutics (搜索), and Novadip (搜索) to integrate its automated platform into clinical trials for therapies targeting blindness, hearing loss, and bone regeneration.
Mytos (搜索), a London-based biotechnology company, has launched its automated contract development and manufacturing organization (CDMO) offering to address one of regenerative medicine's most significant challenges: scalable, affordable manufacturing of stem cell-derived therapies. The first facility, housed within the Cell and Gene Therapy Catapult's Stevenage Manufacturing Innovation Centre, is targeting clinical readiness by September 2026.
Addressing Manufacturing Bottlenecks
The launch comes as the regenerative medicine field faces persistent manufacturing constraints. Producing stem-cell derived therapies manually is slow, expensive, and difficult to scale, requiring scarce, highly trained operators and vulnerable to variability as production increases. Traditional capacity building also demands major upfront capital investment and lengthy installation timelines.
"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 of Mytos (搜索). "With our automated iDEM-powered manufacturing sites, we're addressing that challenge head-on."
Production Capacity and Technology
Powered by Mytos (搜索)' iDEM™ automation technology, the team at the Stevenage site aims to deliver up to 1,500 autologous doses or 25,000 allogeneic doses annually, with additional cleanroom space available to further multiply capacity. The iDEM™ technology is designed to lower cost per dose, accelerate tech transfer by using the same flask format as manual culture, and provide developers immediate access to GMP capacity without traditional infrastructure costs or delays.
The facility represents the first of several planned global sites aimed at building the manufacturing backbone needed to bring regenerative medicines to millions of patients worldwide.
Strategic Partnership with CGT Catapult
Mytos (搜索) 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 been released by companies at the site, with over 40 percent shipped to the United States.
"Mytos (搜索)' automation technology represents an important step forward in addressing the scalability and cost challenges of regenerative medicine manufacturing," said Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult. "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."
CGT Catapult will support Mytos (搜索)' transition to a CDMO by helping the company integrate its technology first into a GMP-mirroring setting before integrating into a GMP module.
Multiple Therapeutic Applications
Mytos (搜索) has secured partnerships with three biotechnology companies to integrate its automated platform into upcoming clinical trials across diverse therapeutic areas. StemSight (搜索), based in Finland, will use the platform to advance development of its iPSC-derived corneal stem cell therapy (搜索) for limbal stem cell deficiency (搜索), a rare cause of corneal blindness (搜索).
UK-based Rinri Therapeutics (搜索) is preparing to bring its lead candidate, Rincell-1, into the clinic for sensorineural hearing loss (搜索) treatment, utilizing Mytos (搜索)' automation to ensure precision and reproducibility in manufacturing otic neural progenitor cells (搜索).
Belgium-based Novadip (搜索) is evaluating the iDEM system to scale output of its autologous products derived from adipose stem cells (搜索) for patients with large bone defects (搜索), expecting the platform to increase production capacity within existing facilities.
Leadership Expansion
To accelerate its CDMO strategy, Mytos (搜索) has strengthened its leadership team with industry veterans. David DiGiusto, Ph.D., former CTO of Semma Therapeutics and Resilience, has joined as an advisor. Barry Oliver, former VP of Global Cell & Gene Therapy Quality at Catalent, joins as interim Head of Quality, and Felix Quagiarello, former Director of Business Development at Cellares, joins as Senior Director of Business Development.
"Automated manufacturing is essential for successful commercialization of regenerative medicine products," said DiGiusto. "I've seen firsthand how difficult it is to scale cell therapies using manual processes. Mytos (搜索)' approach has the potential to define manufacturing standards and expectations by delivering consistent, low-cost batches at the scale needed to reach patients globally."