Why Cellular Manufacturing Matters
Cell therapy has reached a defining moment. After two decades of breakthroughs in immunotherapy and regenerative medicine, the science has outpaced the infrastructure needed to deliver it. Each dose of a cell therapy—whether it’s a CAR-T for leukemia or an iPSC-derived tissue for Parkinson’s—requires the precise manipulation of living cells, often by hand, in small, cleanroom facilities. The result: manufacturing costs that can exceed $200,000 per patient, long production times, and limited availability.
In other words, biology has scaled—but the process to make it hasn’t.
Automated cellular manufacturing is emerging as the solution. By replacing manual steps with robotic precision, closed systems, and data-driven quality control, companies are beginning to produce cell therapies faster, more consistently, and at lower cost. Automation doesn’t just cut expense; it also improves reproducibility and safety. For patients, it could mean broader access to life-saving treatments, faster turnaround from biopsy to infusion, and eventually even on-demand manufacturing at hospitals.
Across the industry, a new generation of startups is reimagining how cells are made. Four stand out for their distinct visions of automation: Cellares, Ori Biotech, Mytos, and Cellino. Together, they illustrate three competing architectures for the factory of the future—centralized, distributed, and point-of-care.
Cellares: The Execution and Scale Leader
San Francisco–based Cellares has become the undisputed pace-setter. Backed by more than $350 million in venture funding and a landmark $380 million partnership with Bristol Myers Squibb, the company has transformed its Cell Shuttle from concept into an industrial platform. Its FDA-recognized Advanced Manufacturing Technology (AMT) designation gives therapy developers a regulatory fast lane for products produced on its automated lines.
Cellares’ “IDMO Smart Factories” in California, New Jersey, and Japan promise high-throughput, end-to-end automation with up to 10× greater batch density than conventional facilities. For now, Cellares stands alone in marrying proven hardware, major-pharma customers, and regulatory validation—an execution trifecta that positions it as the front-runner.
Ori Biotech: The Ecosystem Builder
While Cellares builds factories, Ori Biotech is building the ecosystem. Its IRO® platform—a compact, closed, digital manufacturing unit—earned its own FDA AMT nod in 2025 and is rapidly spreading through a Preferred Partner Network that includes Charles River Labs, ElevateBio, CTMC (MD Anderson + Resilience), and Kincell Bio.
Rather than owning capacity, Ori embeds its technology inside the existing supply chain, enabling partners to automate their own CGT production. This distributed-adoption model requires less capital and could establish IRO as the industry’s default standard for small-footprint, data-rich cell-therapy manufacturing.
Mytos: The Focused Challenger
London-based Mytos operates one stage earlier in maturity but is moving fast. Its iDEM™ automation system powers the company’s new CDMO facility inside the UK’s CGT Catapult Stevenage Hub, scheduled for GMP output in 2026. Early partnerships with Novadip Biosciences, Rinri Therapeutics, StemSight, and Aspen Neuroscience show that regenerative-medicine developers see value in Mytos’ approach—automating familiar flask-based workflows rather than reinventing them.
With only about $20 million raised so far, Mytos must now prove it can scale manufacturing efficiently and secure the larger Series B funding needed to replicate its model across Europe and the U.S.
Cellino: The Ambitious Outlier
Boston-based Cellino plays a different game entirely. Armed with an $80 million Series A and up to $25 million from ARPA-H, Cellino is developing laser- and AI-driven autonomous systems to manufacture personalized iPSC-derived cells directly from a patient’s sample. Its five-year ARPA-H project, NEBULA, envisions modular “cell-factory” units that could one day sit inside hospitals.
The upside is enormous—true point-of-care regenerative manufacturing—but so are the headwinds. The technology remains pre-commercial, regulatory pathways for autologous iPSC therapies are uncharted, and revenue is still years away. Cellino is the moonshot of the group: high-risk, potentially transformative.
The Competitive Landscape
- Taking off now: Cellares (commercial-scale deployment + BMS deal + FDA AMT) and Ori Biotech (broad embedded adoption + AMT designation).
- Rising fast but earlier stage: Mytos (specialized stem-cell CDMO launching its first GMP site).
- High-risk/high-reward outlier: Cellino (personalized iPSC manufacturing backed by ARPA-H).
Outlook
The trajectory is clear: Cellares and Ori have crossed from R&D into industrial execution, setting early standards for automated, closed, regulatory-ready cell-manufacturing systems. Mytos is proving that smaller, modular CDMOs can follow. And Cellino, if successful, could eventually redefine what “distributed manufacturing” means altogether—moving it from the factory floor to the hospital bedside.
The Business of Biofabrication 
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