First site, powered by Mytos iDEM technology, opens within Cell and Gene Therapy Catapult's Stevenage Manufacturing Innovation Centre
Mytos, a biotechnology company automating cell manufacturing, today announced the launch of its automated contract development and manufacturing organization (CDMO) offering, to overcome one of regenerative medicine's greatest bottlenecks: scalable, affordable manufacturing of stem cell-derived therapies.
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Cell and Gene Therapy Catapult's Stevenage Manufacturing Innovation Centre Photo credit: Cell and Gene Therapy Catapult
The first facility, housed within the Cell and Gene Therapy Catapult's (CGT Catapult) Stevenage Manufacturing Innovation Centre, is targeting 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.
Mytos selected the CGT Catapult's Stevenage Manufacturing Innovation Centre as its launch site to leverage the organization's world-class expertise and track record. Over 200 patient batches have already released by companies at the site, and over 40 percent of these batches were shipped to the United States. CGT Catapult will collaborate with Mytos and continue to innovate, test and validate manufacturing technology across GMP, supply chain, automation and digitisation. Importantly, CGT Catapult will support with de-risking Mytos' transition to a CDMO, by helping the company integrate its technology first into a GMP-mirroring setting, before integrating into a GMP module.
"We are very pleased to host Mytos' first CDMO facility at our Manufacturing Innovation Centre," said Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult. "Mytos' automation technology represents an important step forward in addressing the scalability and cost challenges of regenerative medicine manufacturing. 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."
To accelerate its CDMO strategy, Mytos has also strengthened its leadership team. David DiGiusto, Ph.D., former CTO 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 David DiGiusto, Ph.D. "I've seen firsthand how difficult it is to scale cell therapies using manual processes. Mytos' approach has the potential to define manufacturing standards and expectations by delivering consistent, low-cost batches at the scale needed to reach patients globally. I'm thrilled to join this team, who are executing with focus and urgency to address one of the biggest bottlenecks in regenerative medicine."
About Mytos
Mytos is a leader in automated cell manufacture. The company's platform enables life sciences companies to grow human cells with unparalleled precision and efficiency. Mytos has assembled a world-class team of engineers and scientists to develop an automated platform to accelerate the development of life-saving therapies. The company is based in London, UK. For more information, visit www.mytos.bio.
About the Cell and Gene Therapy Catapult
Cell and Gene Therapy Catapult is an independent innovation and technology organization committed to the advancement of the cell and gene therapy industry with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. Cell and Gene Therapy Catapult was established by and works in partnership with Innovate UK.
For more information: https://ct.catapult.org.uk
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