Imagine brilliant scientists spending 10-hour days peering through microscopes, delicately scraping away bad stem cell colonies with a pipette tip—an artisanal, months-long process that costs hundreds of thousands of dollars per patient. This is the monumental bottleneck preventing revolutionary stem cell therapies from reaching the millions who need them. In this conversation, physicist and CEO Nabiha Saklayen explains how her company, Cellino, is tackling this problem by automating the entire manufacturing process for induced pluripotent stem cells (iPSCs). The goal is to shrink a high-stakes clean room operation down to a closed, iPhone-sized cassette that uses AI and lasers to cultivate perfect, patient-matched cells at scale.

Saklayen’s journey into biotech was personal, sparked by losing her grandmother to complications from diabetes and feeling helpless in the face of medical limitations. She pivoted from a physics PhD at Harvard to applying laser precision to biology. The discussion details how Cellino’s platform works: it uses continuous imaging to train AI algorithms that recognize healthy cell development patterns over time—akin to predicting a movie’s genre from its opening scenes—and then uses laser bioprocessing to automate the meticulous selection and nurturing of cells. The company is actively collaborating with the FDA and has partnered with a Parkinson’s trial at Mass General Brigham to transition their manual cell production to Cellino’s automated machines.

The potential impact is staggering. If successful, this automation could make autologous (patient-specific) cell therapies viable for common diseases. Currently, even proven cell therapies like CAR-T only reach about 10,000 patients annually due to manufacturing constraints. Saklayen envisions a near future where a Parkinson’s patient could get a prescription, provide a blood sample, and return months later for a transplant of their own lab-grown neurons—all powered by a standardized machine in a hospital. The broader mission is to shift medicine from managing symptoms to offering curative, regenerative treatments that are accessible to all.

Surprising Insights

• The FDA is described as surprisingly technology-forward, with a dedicated AI team that deeply examines the algorithms behind automated biomanufacturing, actively collaborating to solve scale issues.
• The “artisanal” process of making iPSCs is shockingly manual and fragile, requiring scientists to visually identify “smiley faces” or other patterns in cell colonies and physically scrape away imperfections, with entire batches failing if a specialist misses a day.
• AI is trained not just on static images but on “time series data”—like a time-lapse video of cell growth—allowing it to predict a colony’s future health early on and intervene, increasing efficiency.
• Japan is leading the first regulatory approvals for iPSC therapies, particularly for Parkinson’s and heart disease, due to a strong national focus following the Nobel Prize awarded for the discovery of iPSCs.

Practical Takeaways

• For tackling complex problems, interdisciplinary thinking is powerful. Saklayen’s physics background in lasers provided an unconventional solution to a biological manufacturing bottleneck.
• When building for the future, constantly pressure-test for scale. She advises always asking, “Could this solution address a million patients annually?” to avoid short-term shortcuts that hinder long-term growth.
• Collaboration with regulators early on can be a catalyst. Proactively working with the FDA can help shape new frameworks for innovative technologies.
• Passion and personal mission drive resilience. The collective willpower in the biotech field, often fueled by personal experiences with disease, is what sustains progress through difficult markets and technical hurdles.