Cellares Extends Cell Therapy Automation Beyond T Cell Therapies

Cellares is extending its automated cell therapy manufacturing platforms to gene-edited hematopoietic stem cell (HSC) therapies, marking a step toward standardized production of complex, potentially curative treatments. Through a collaboration with Stanford Center for Definitive and Curative Medicine (CDCM) and the Stanford Innovative Medicines Accelerator, announced Feb. 3, 2026, the company aims to automate manufacturing and release testing for gene-edited HSCs, expanding beyond its earlier focus on T cell therapies (1).

Under the collaboration, Cellares will establish a standardized platform manufacturing process on its Cell Shuttle system alongside platform release assays on Cell Q, designed for automated quality control. These processes are intended to apply across multiple disease indications, reducing the need to redesign manufacturing workflows for each new therapy. Automation activities are already underway using a safe harbor knock-in gene-editing strategy, known as harbor knock, which is designed to support consistent gene insertion across different programs, according to the company.

“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,” said Fabian Gerlinghaus, co-founder and CEO, Cellares, in a company press release (1). “With Stanford Medicine, we’re building a manufacturing and analytical foundation that can be applied across many rare disease programs to improve patient access.”

Why is manufacturing automation critical for gene-edited stem cell therapies?

Gene-edited HSCs are being developed as durable, potentially one-time treatments that rebuild the blood and immune system with corrected cells. Programs targeting HIV and a growing number of rare inherited diseases are advancing in academic and early clinical settings, but manufacturing scalability remains a major constraint. Many of these diseases lack effective treatment options, increasing pressure on developers to establish reliable production approaches that can support broader patient access (1).

Manufacturing gene-edited HSCs is technically complex and often relies on labor-intensive, manual processes. These approaches can introduce variability, limit throughput, and increase costs as programs move toward clinical development. For therapies intended as single-administration interventions, inconsistent manufacturing performance can undermine both safety and commercial viability (2).

By automating end-to-end production and release testing, the collaboration seeks to reduce hands-on variability and establish a scalable foundation that can support multiple programs.

How could platform processes change the economics of stem cell therapies?

Standardized manufacturing and analytical platforms could significantly improve process reliability and batch success rates while lowering per-patient costs. These factors are especially important for rare diseases and global health applications, where affordability and supply constraints often limit adoption even when promising therapies exist (2).

According to Cellares, the research group of Matthew Porteus, MD, PhD, director of the CDCM at Stanford University School of Medicine, has developed a gene-editing approach applicable across HIV and a wide range of monogenic diseases. Identifying a manufacturing process that is consistent and scalable, however, has remained a central challenge. Automation technologies offer a potential path to remove this barrier by enabling more predictable and repeatable production (2).

What does this collaboration mean for the future of cell therapy manufacturing?

By extending its automation platforms beyond T cell therapies, Cellares is positioning its integrated development and manufacturing model to support multiple cell modalities using a common technological backbone. This reflects a broader industry shift away from bespoke, indication-specific manufacturing toward platform-based systems that can accommodate diverse pipelines more efficiently (2).

As gene-edited stem cell therapies continue to expand in scope, collaborations that integrate academic innovation with automated manufacturing infrastructure may play a defining role in how quickly these therapies move into the clinic and reach broader patient populations (3).

References

1. Cellares. Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies. Press Release. Feb. 3, 2026.
2. Wang, X.; Rivière, I. Genetic Engineering and Manufacturing of Hematopoietic Stem Cells. Mol. Ther.—Methods Clin. Dev. 2017, 5, 96–105. DOI: 10.1016/j.omtm.2017.03.003
3. National Academies of Sciences, Engineering, and Medicine; et al. Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies: Proceedings of a Workshop—in Brief; Beachy, S. H.; Alper, J.; Drewry, M., Eds.; National Academies Press, 2024. DOI: 10.17226/27483