Scale to millions of patients with automated manufacturing.
1×
Tech Transfer To protect your timeline through the clinic
10×
Batches Per Cleanroom
40%
Lower Cost Per batch
25x
Reduction in Operator Failures Vs manual production
How we work with you. Four steps from your protocol to clinical-grade supply.
Rapidly prove technical fit and ROI.
Our scientists rapidly translate your manual
process to iDEM to meet your success criteria.
GMP manufacturing at our MHRA-licensed production site.
Rapidly scale to meet patientdemand with predictable
supply and costs.
Mytos Site 1 is live in the UK today, with a phased rollout to global sites.
1.5K Autologous Doses
or 25K Allogeneic Doses
United Kingdom Launched 2025
North America Phase 2
Japan Phase 3
We meet your program at any stage.
Process Development Transferable and scalable processes from day one.
Analytical Development Fit-for-purpose assays for identity, potency, and purity.
Clinical GMP Manufacturing One-stop-shop for clinical material.
Regulatory Support Submission-ready documentation.
Multi-site Validation Automation to make comparability demonstrable, not aspirational.
Commercial Supply Meet demand without hiring and training bottlenecks.
Reach commercial supply 3–5 years faster.
"Mytos offered a unique and practical bridge from manual to automated production, even at an early stage."
Dr. Laura Koivusalo CEO · StemSight
"With Mytos, we have the opportunity to seamlessly automate our existing process without having to change the biology."
Dr. Terri Gaskell CTO · Rinri Therapeutics
"Mytos enables us to increase the output of our existing facilities, without having to delay scaling to build out new capacity."
Neil Johnson CTO · Novadip Biosciences
Manufacture with us.
You bring the protocol. We bring the facility, the team, and regulatory path.
Frequently asked questions
The iDEM system is designed & manufactured under a QMS to meet the requirements of GMP Manufacturing. IOQ & regulatory support packages available.
Yes. MytosOS provides configurable operator sign offs/alerting, electronic batch records, deviation management, and is ALCOA+ compliant — all purpose-built for GMP cell therapy manufacturing.
GMP-grade consumables are currently available for early access partners. General availability is planned for Q3 2026.
Yes. Mytos provides full IQ/OQ and support your team with PQ. Full validation support is also available.
Mytos supports clinical & commercial partners through provision of DMFs, risk assessments, and change control documentation. Our regulatory team supports FDA, EMA, and MHRA submissions.