Cellares, TScan Partner on Automated TSC-101 Manufacturing
Cellares and TScan Therapeutics have entered into a strategic agreement to evaluate automated clinical manufacturing of TSC-101, an investigational T cell receptor-engineered T cell (TCR-T) therapy being developed for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The collaboration will focus on assessing the feasibility of using Cellares’ automated manufacturing and testing technologies to support the production of TSC-101 as the therapy advances toward late-stage clinical development and potential commercialization.
TSC-101 is designed to address residual disease and reduce the risk of relapse in AML and MDS patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The therapy utilizes genetically engineered T cells derived from healthy donors and customized for individual patients. TScan is preparing to launch a pivotal clinical trial for TSC-101 in the second quarter of 2026 and is exploring scalable manufacturing solutions to meet future commercial demand.
Under the terms of the agreement, Cellares will adapt the TSC-101 manufacturing and testing processes to its Cell Shuttle platform, an end-to-end automated manufacturing system, and its Cell Q platform, an automated quality control and release testing solution. The company believes these technologies can streamline production by reducing manual intervention, minimizing process variability, and improving consistency across manufacturing sites.
The evaluation reflects a broader trend within the cell therapy industry, where developers are increasingly seeking automation to overcome manufacturing bottlenecks and lower production costs. Cell therapies often require highly specialized, labor-intensive manufacturing processes that can limit scalability and patient access. Automated systems are viewed as a potential solution to support larger patient populations while maintaining product quality and reliability.
Ray Lockard, Chief Manufacturing and Quality Officer at TScan Therapeutics, said the company is intensifying efforts to ensure commercial readiness as TSC-101 progresses toward pivotal-stage development. He noted that establishing a cost-effective and scalable manufacturing strategy is essential for supporting future patient demand and expanding access to advanced cell therapies.
Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares, emphasized the importance of automation for treating patients who remain at risk of disease relapse following transplantation. He stated that TSC-101’s donor-derived yet patient-specific manufacturing model represents a compelling use case for the company’s automated production technologies.
The agreement further expands Cellares’ portfolio of automated cell therapy programs, which already includes collaborations involving CAR-T therapies, hematopoietic stem cell applications, and autologous progenitor T cell therapies. The partnership underscores the growing emphasis on manufacturing innovation as the cell and gene therapy sector seeks to bring complex personalized treatments to a broader patient population.