Cellares Scales IDMO Model for Gene-Edited Stem Cells Therapies

Cellares has announced a strategic expansion of its automated manufacturing capabilities to include gene-edited hematopoietic stem cell therapies.¹ The initiative, established through a collaboration with the Stanford Center for Definitive and Curative Medicine and the Stanford Innovative Medicines Accelerator, moves the application of high-throughput automation beyond T cell therapies into a new cell modality. The development represents a critical step in industrializing treatments for conditions such as HIV and more than 19 rare inherited diseases. By automating manufacturing and release testing, the collaboration aims to replace labor-intensive, manual steps with a standardized platform designed to support academic innovation as it moves toward clinical development.

Why Is High-Throughput Automation Necessary for Gene-Edited Stem Cells

The transition to automated systems is intended to solve persistent manufacturing challenges related to capacity and consistency.¹ Traditional methods for producing gene-edited stem cell therapies often rely on manual, lab-based processes that are difficult to scale. Matthew Porteus, MD, PhD, whose lab at the Stanford University School of Medicine developed the stem cell gene-editing approach, noted in a Cellares press release that the company’s technology in automation could remove the barrier to making therapies more cost effective and accessible.¹ The current project involves establishing standardized manufacturing processes on the Cell Shuttle platform and release assays on the Cell Q platform to ensure high-throughput quality control.

This expansion into new modalities follows a $257 million Series D financing round, which Cellares announced last week and closed to scale its automated manufacturing model globally.² This significant capital infusion serves to validate the industry's shift toward the integrated development and manufacturing organization, or IDMO. The IDMO model focuses on vertical integration across technology development and contract manufacturing to reduce costs and improve the reach of personalized medicines. Fabian Gerlinghaus, co-founder and CEO of Cellares, stated that “Gene-edited hematopoietic stem cells have the potential to address the root cause of disease for patients who today have limited or no treatment options.”¹

How Does the IDMO Model Facilitate Global Scaling and Reliability?

For biopharmaceutical organizations, the IDMO model offers a potential 90% reduction in required labor and facility space compared with conventional methods.² This efficiency is achieved through a digital backbone that connects automated instruments to maintain the chain of custody and auto-generate electronic batch records. Gerlinghaus explains to PharmTech that the IDMO approach “eliminates middle-men which helps Cellares offer the lowest cost of manufacturing in the industry - the other contributing factors being a 90% reduction in required labor and facility space.”² By integrating manufacturing and quality control, these platforms can achieve approximately ten times the throughput of a traditional contract development and manufacturing organization.

The move toward an automated, software-driven process allows for greater flexibility during development while maintaining strict regulatory standards.² For instance, the Cell Q platform feeds quality control data directly into electronic records, addressing the bottleneck that typically occurs as production volumes increase. Gerlinghaus notes that “this removes the quality control bottleneck that typically emerges when manufacturing throughput increases but QC remains manual. Where manual cell therapy manufacturing involves writing 500 pages of quality documentation by hand on paper, Cellares is moving the industry from paper to electronic batch records and from manual generation to auto-generation.” This infrastructure is supported by an advanced manufacturing technology designation from FDA, which enables partners to seek expedited regulatory reviews. As the industry moves toward commercial-scale operations in 2027, the focus is increasingly on building the industrial backbone required to meet global patient demand.^1,2

References

1. Cellares. Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies. Press release. Feb 3, 2026.
2. Cellares. Cellares Raises $257 Million Series D Led by BlackRock and Eclipse to Industrialize Global Cell Therapy Manufacturing with Breakthrough Automation. Press release. Jan 28, 2026.