iOrganBio today announced its official launch from stealth mode, backed by $2 million in funding intended to revolutionize the production of human cells. The funding round was led by First Star Ventures, with participation from institutional investors including IndieBio, Cape Fear BioCapital, 2ndF, Terasaki Institute, and Alix Ventures.

“The future of human health depends on our ability to intelligently design human cells and organoids with the same precision and reliability we expect from any other industrialized process," said Daniel Delubac, co-founder and CEO of iOrganBio.

The company’s proprietary CellForge™ platform integrates AI-driven predictions with high-throughput experimental control, enabling the engineering of cells and organoids across various high-value areas, including drug discovery, manufacturing, and cell therapies. This groundbreaking platform utilizes closed-loop control of 3D culture environments to optimize culture conditions dynamically during human pluripotent stem cell (hPSC) differentiation. By innovating the engineering and application of human cells, iOrganBio aims to deliver predictable, reproducible, and scalable outcomes across diverse cell types derived from stem cells and peripheral blood cells. This unique methodology could significantly assist biopharma partners in accelerating disease modeling, regenerative medicine, and drug development.

“With CellForge, we are seeking to create a new standard for cell manufacturing—one that is configurable, reproducible, and scalable, and adapted to living products,” noted Delubac.

Central to CellForge is the Functional Human CellAtlas™, a comprehensive and expanding repository of human cell data obtained from single-cell RNA sequencing and other high-resolution profiling techniques. This foundation equips CellForge to guide cell development with unmatched precision, allowing partners to target specific cell states and utilize them for designing and manufacturing tissues and organoids at both the population and single-cell levels. The outcome is enhanced precision and reliability for any process or application reliant on human cells, from model development to therapeutic production.

CellForge's versatility allows it to be applied in numerous contexts to create advanced tissue models and innovative cell therapies. So far, the platform has successfully identified specific beta islet cells to inform organoid and tissue design, resulting in pancreas models with tailored properties, such as optional vasculature and immune competency, suitable for disease modeling, drug testing, and regenerative applications.

iOrganBio was founded in 2024 by Dr. Daniel Delubac (formerly of Guardant Health, Freenome, and Chemify), Dr. Shuibing Chen (Weill Cornell Medicine), and Prof. Xiling Shen (MD Anderson Cancer Centers, Terasaki Institute for Biomedical Innovation). The platform is rooted in pioneering science from Dr. Chen’s lab at Weill Cornell Medicine. Together, these distinguished experts in hPSC differentiation and manufacturing process automation have developed CellForge to tackle five critical bottlenecks affecting accessibility and cost in cell-based therapies and disease modeling:

- Definability: Establishing exact target characteristics through a digitally defined cell profile.
- Generalizability: Developing diverse cell types to broaden access to advanced models and therapies.
- Adaptability: Using multiple cell sources to enable rapid adjustment to new applications.
- Reproducibility: Achieving consistent target profiles to reduce batch-to-batch variability.
- Scalability: Expanding from small-scale experiments to high-volume production for clinical and commercial needs.

“As a scientist, one of the most rewarding moments is seeing your discoveries move beyond the lab and begin transforming how we use human cells in the real world,” stated Dr. Chen, co-founder, Board of Directors member, Senior Scientific Advisor of iOrganBio and the Kilts Family Professor of Surgery at Weill Cornell Medicine. “By scaling the engineering of cells that reflect true human biology, we’re opening the door to breakthroughs across drug discovery and patient care.”

“Pharma has long needed human-relevant models that can reliably predict how therapies will work in the clinic. The level of engineering precision by iOrganBio’s technology uniquely positions the company to become an indispensable partner,” added Drew Volpe, Founding Partner of First Star Ventures. “Their digital-first approach, grounded in AI and data, will dramatically reduce costs and accelerate the path from idea to therapy.”

About iOrganBio

iOrganBio is pioneering the transformation of human cell production with CellForge, its AI-powered platform designed for consistent, scalable, and intelligent manufacturing of cells and organoids for in vitro modeling and cell therapies. By applying engineering precision to biology, CellForge leverages AI and automation to steer cell development and make real-time adjustments that align with defined biological profiles. At the heart of the platform is iOrganBio’s Functional Human Cell Atlas, an extensive reference built from single-cell and multi-omics data that provides digital blueprints for each cell type. This smart, closed-loop process delivers the accuracy, efficiency, and quality that partners require to convert scientific ideas into breakthroughs—accelerating disease modeling, regenerative medicine, and drug development. iOrganBio is located at BioLabs in Chapel Hill, NC.

For more information, visit iOrgan.Bio or follow us on LinkedIn.