Cellares, Stanford team to automate gene-edited HSC manufacturing
Cellares, an integrated development and manufacturing organization for cell therapies, has entered into a collaboration with Stanford University School of Medicine to automate manufacturing and release testing for gene-edited hematopoietic stem cell (HSC) therapies. The effort expands the application of Cellares’ automation platforms beyond T cell therapies into an additional cell modality.
Under the collaboration, Cellares will establish a standardized platform manufacturing process on its Cell Shuttle system and platform release assays on its Cell Q system, designed to be applied across multiple indications. Automation activities are already underway using the safe harbor knock-in gene-editing approach, the company said.
Gene-edited HSCs are being developed as potentially durable, one-time treatments intended to rebuild the blood and immune system for patients with HIV and certain inherited diseases, according to the announcement. Many of these conditions currently lack effective treatment options, increasing the importance of scalable and reliable manufacturing approaches as programs advance toward clinical development.
The teaming is supported by Stanford’s Innovative Medicines Accelerator and the Center for Definitive and Curative Medicine and is intended to reduce hands-on variability, while creating a scalable manufacturing foundation to help translate academic research into clinical programs, the organizations said.
“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,” Cellares CEO Fabian Gerlinghaus said in a statement. “With Stanford Medicine, we’re building a manufacturing and analytical foundation that can be applied across many rare disease programs to improve patient access.”
Separately, Cellares announced last week that it raised $257 million in a Series D financing round to support global deployment of its automated, GMP-ready manufacturing facilities in the U.S., Europe, and Japan. The company said the funding will support the buildout of facilities intended for clinical manufacturing beginning in the first half of 2026, with commercial-scale manufacturing expected to start in 2027.