Cellares to Expand Automated Manufacturing to Gene-Edited Stem Cell Therapies

Collaboration with Stanford Medicine establishes a platform manufacturing process and analytics designed to support gene-edited hematopoietic stem cell therapies for HIV and more than 19 rare diseases

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced a collaboration with the Stanford Center for Definitive and Curative Medicine (CDCM) and Stanford Innovative Medicines Accelerator (IMA) to automate manufacturing and release testing for gene-edited hematopoietic stem cell (HSC) therapies, expanding the application of Cellares’ automation platforms beyond T cell therapies into a new cell modality.

Gene-edited HSCs are being developed as durable, potentially one-time treatments that rebuild the blood and immune system with corrected cells for patients with HIV and rare inherited diseases. Many of these conditions currently lack effective treatment options, highlighting the need for scalable, reliable manufacturing approaches that can support patient access as programs advance.

Under the collaboration, Cellares will establish a standardized platform manufacturing process on the Cell Shuttle™ and platform release assays on the Cell Q™, designed to apply across multiple indications. Automation efforts are already underway with the HARBOR KNOCK (safe harbor knock-in) gene-editing approach.

The effort is supported by the Stanford Innovative Medicines Accelerator (IMA) and Stanford Medicine Center for Definitive and Curative Medicine (CDCM). The collaboration aims to reduce hands-on variability and create a scalable foundation to help move academic innovation toward clinical development.

Matthew Porteus, MD, PhD, Director of the CDCM at Stanford University School of Medicine, and his lab, have developed an HSC gene-editing approach that can be applied across HIV and a wide range of monogenic diseases. One of their goals is to identify a manufacturing process that is consistent and scalable. Cellares’ technology in automation could remove the barrier to making therapies more cost effective and accessible.

“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 of Cellares. “With Stanford Medicine, we’re building a manufacturing and analytical foundation that can be applied across many rare disease programs to improve patient access.”

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

Cellares’ fully automated platforms — Cell Shuttle™ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.

Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.