Cellares, TScan Partner on Automated CAR-T Manufacturing

Cellares and TScan Therapeutics have formed a partnership to evaluate automated manufacturing capabilities for TSC-101, an investigational cell therapy for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The agreement centers on a comprehensive technical and operational assessment of Cellares' manufacturing automation platforms as TScan prepares for increased production demands. The company plans to initiate a pivotal clinical trial for TSC-101 in the second quarter of 2026.

Automation infrastructure for donor-derived therapies

Cellares will deploy two core systems under the partnership. The Cell Shuttle platform will handle automated manufacturing and testing of TSC-101, while the Cell Q system will manage quality control and release testing procedures. The integrated approach aims to deliver reproducible results while reducing variability and manual labor requirements inherent in traditional cell therapy production.

TSC-101 represents a distinct manufacturing challenge because it uses gene-modified T cells from healthy donors to create patient-specific therapies. The treatment targets residual disease in AML and MDS patients following allogeneic hematopoietic cell transplantation, a population at continued risk for relapse.

Why it matters

Automated manufacturing could determine whether personalized cell therapies reach broader patient populations at sustainable costs. TSC-101's donor-derived, patient-specific model requires production economics that traditional manual processes struggle to deliver at commercial scale. Success in automating this manufacturing approach could establish a template for similar therapies targeting underserved patient groups where treatment demand exceeds current production capacity.

Expanding the automation portfolio

The TScan collaboration extends Cellares' automated platform beyond its existing applications. The company's systems already support CAR-T cell therapies, hematopoietic stem cell programs, and autologous progenitor T cell therapies. Adding TCR-engineered T cell therapies like TSC-101 broadens the range of cell therapy modalities compatible with the automation infrastructure.

Fabian Gerlinghaus, co-founder and CEO of Cellares, characterized the partnership as addressing a manufacturing challenge the company's platforms were designed to solve. He emphasized that patients with AML or MDS facing post-transplant relapse risk represent an underserved population requiring the scale and economics that automation can provide.

As TScan advances TSC-101 toward late-stage development and potential commercialization, the company is evaluating whether Cellares' automated systems offer a viable path to scalable, cost-effective production.

The partnership details were first reported by Pharmaceutical Technology.