Pharmaceutical Business review

Cellares and TScan to assess automated manufacturing of TSC-101 therapy

With the agreement, TCR-engineered T cell therapies such as TSC-101 become part of Cellares’ automated platform portfolio. Credit: PeopleImages / Shutterstock.com.

The collaboration aims to conduct a full technical and operational assessment of Cellares’ automated manufacturing and testing platforms.

This is in preparation for the anticipated demand surrounding TSC-101 as it advances towards a pivotal clinical trial scheduled to start in the second quarter (Q2) of 2026.

Under the agreement, Cellares will use its Cell Shuttle platform to automate the manufacturing and testing of TSC-101, along with the Cell Q system to automate quality control and release testing.

Together, these systems are designed to deliver consistent performance, reduce process variability, and minimise manual intervention, supporting the demands of large-scale commercial manufacturing.

Cellares co-founder and CEO Fabian Gerlinghaus said: “Patients with AML or MDS who remain at risk of relapse following transplant represent exactly the kind of underserved population that automated manufacturing was designed to reach.

“Bringing automation to a late-stage programme like TSC-101, with its healthy donor-derived but patient-specific manufacturing model, is the kind of challenge the Cell Shuttle and Cell Q were built for, and we believe it represents the manufacturing economics any developer will need to reach a population of this scale.”

TSC-101 is being investigated as a treatment intended to address residual disease and prevent relapse in individuals with AML and MDS following allogeneic haematopoietic cell transplantation.

The candidate relies on gene modification technology to convert healthy donor T cells into bespoke cell therapy products for patients.

As TScan pursues further development and commercialisation strategies for TSC-101, the company is considering Cellares’ automated platform as a possible scalable and cost-effective option.

With this agreement, TCR-engineered T cell therapies, such as TSC-101, become part of Cellares’ automated platform portfolio.

This collection already includes CAR-T cell therapies, haematopoietic stem cell programmes, and autologous progenitor T cell therapies.