Cellares and TScan Therapeutics Collaborate to Evaluate Automated Manufacturing for TSC-101 TCR-T Therapy in AML and MDS
Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company developing T cell receptor-engineered T cell (TCR-T) therapies for cancer, have announced a new collaboration agreement to evaluate automated clinical manufacturing for TScan’s lead candidate, TSC-101, in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The collaboration will focus on assessing the feasibility, scalability, and operational efficiency of Cellares’ automated cell therapy manufacturing and quality control platforms for potential use in late-stage clinical and future commercial production of TSC-101. As TScan prepares for a pivotal clinical trial expected to begin in the second quarter of 2026, the company is actively exploring advanced manufacturing solutions designed to support future commercialization and broader patient access.
Advancing Manufacturing Innovation for TCR-T Cell Therapy
TSC-101 is a next-generation TCR-engineered T cell therapy designed to address residual disease and reduce relapse risk in patients with AML and MDS who have undergone allogeneic hematopoietic cell transplantation (allo-HCT). These patients represent a high-risk population, where disease recurrence after transplant remains a significant clinical challenge and a major cause of treatment failure.
The therapy works by genetically modifying T cells derived from healthy donors, engineering them to recognize and target specific cancer-associated antigens. This approach allows for the creation of a patient-specific cellular therapy product that can be administered to eliminate residual malignant cells following transplantation.
As TScan advances TSC-101 toward late-stage development, manufacturing scalability and consistency have become increasingly important considerations. Cell therapy manufacturing is typically complex, labor-intensive, and highly sensitive to process variability, creating challenges in achieving the reproducibility and cost efficiency required for commercial-scale production.
To address these challenges, TScan is evaluating Cellares’ fully automated manufacturing ecosystem as a potential solution to support both clinical trial supply and long-term commercial demand.
Evaluation of Cellares’ Integrated Automation Platform
Under the terms of the agreement, Cellares will apply its integrated manufacturing and quality control systems to the production process for TSC-101. This includes use of the Cell Shuttle, an end-to-end automated manufacturing platform, and the Cell Q, an automated system for quality control and product release testing.
Together, these systems are designed to create closed, standardized manufacturing workflows that reduce manual intervention and improve consistency across production batches. By automating key steps in cell therapy manufacturing, the platform aims to minimize variability, increase throughput, and enhance overall manufacturing reliability.
The Cell Shuttle platform is intended to support the full production lifecycle of cell therapies, from cell processing and genetic modification to expansion and formulation. The Cell Q system complements this by providing automated analytical testing and quality assurance, ensuring that each manufactured batch meets predefined release criteria.
For therapies such as TSC-101, which rely on donor-derived but patient-specific manufacturing models, such automation is particularly relevant. It enables developers to produce complex therapies at scale while maintaining strict quality standards and reducing dependency on manual processes that can introduce variability and increase production costs.
Preparing for Late-Stage Clinical Development
TScan Therapeutics is currently advancing TSC-101 toward a pivotal clinical trial anticipated to begin in the second quarter of 2026. As part of this transition into late-stage development, the company is placing increased emphasis on manufacturing readiness and commercial scalability.
According to TScan, establishing a reliable and cost-effective manufacturing strategy is a critical component of its long-term development plan. Cell therapies often face significant challenges when transitioning from early clinical production to commercial-scale manufacturing, particularly in terms of capacity, reproducibility, and cost per dose.
By evaluating Cellares’ automated platform, TScan aims to assess whether this technology can help address these challenges and support a more scalable manufacturing infrastructure. The goal is to ensure that if TSC-101 demonstrates clinical success, the company will be positioned to supply the therapy efficiently to a broader patient population without significant manufacturing bottlenecks.
Ray Lockard, M.B.A., Chief Manufacturing and Quality Officer of TScan Therapeutics, emphasized the importance of this initiative as the company moves closer to pivotal clinical development. He noted that commercial readiness is becoming a central focus, particularly as TScan prepares to initiate its next phase of clinical evaluation.
He highlighted that Cellares’ Cell Shuttle platform represents a promising approach to automating and scaling cell therapy production, with the potential to reduce manual processing steps and eliminate capacity constraints that are common in traditional manufacturing systems. The evaluation is intended to determine how such technologies could strengthen TScan’s long-term manufacturing network and improve the company’s ability to deliver therapies efficiently and reliably to patients in need.
Cellares’ Perspective on Expanding Access Through Automation
From Cellares’ perspective, the collaboration with TScan Therapeutics represents an opportunity to apply its automation platform to a late-stage, donor-derived T cell therapy program targeting a high-risk patient population.
Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares, highlighted the unmet medical need in AML and MDS patients who remain vulnerable to relapse following hematopoietic stem cell transplantation. He noted that these patients represent exactly the type of population that automated cell therapy manufacturing is designed to serve—where scalability, speed, and cost efficiency are essential to enabling widespread access.
He also emphasized that the Cell Shuttle and Cell Q systems were specifically developed to address the challenges associated with complex cell therapy manufacturing models, including those that rely on patient-specific or donor-derived cell products. According to Gerlinghaus, applying this technology to a late-stage program such as TSC-101 provides a strong opportunity to demonstrate how automation can support both clinical development and future commercial supply at scale.
Expanding Cellares’ Cell Therapy Manufacturing Portfolio
The agreement also expands Cellares’ growing portfolio of automated manufacturing collaborations across multiple cell therapy modalities. The company’s integrated platform is currently being applied to a range of therapeutic approaches, including CAR-T cell therapies, hematopoietic stem cell-based programs, and autologous progenitor T cell therapies.
By extending its technology to TCR-engineered T cell therapies such as TSC-101, Cellares continues to broaden its role as an infrastructure provider for next-generation cell therapy manufacturing. The company’s IDMO model is designed to combine process development, manufacturing, and quality control within a single automated ecosystem, reducing complexity and improving scalability for therapy developers.
Addressing Manufacturing Challenges in Cell Therapy
Cell therapy manufacturing remains one of the most complex and resource-intensive areas of modern biotechnology. Traditional production methods often rely heavily on manual processing steps, specialized facilities, and highly trained personnel, all of which can limit scalability and increase production costs.
These challenges become even more pronounced as therapies move from early clinical trials into late-stage development and potential commercialization. Ensuring consistent product quality, maintaining supply chain reliability, and achieving cost efficiency are all critical factors in determining whether a cell therapy can reach a broad patient population.
Automation platforms such as those developed by Cellares aim to address these limitations by standardizing manufacturing workflows and reducing dependence on manual intervention. By doing so, they seek to enable more predictable production outcomes and support the large-scale deployment of advanced therapies.
The collaboration between Cellares and TScan Therapeutics marks an important step in evaluating how automated manufacturing technologies can support the next generation of T cell therapies. As TScan advances TSC-101 toward pivotal clinical testing, the ability to ensure scalable, cost-efficient, and reliable manufacturing will play a crucial role in determining the therapy’s long-term commercial viability.
For Cellares, the agreement further demonstrates the versatility of its Cell Shuttle and Cell Q platforms across multiple cell therapy modalities, reinforcing its position as a key infrastructure provider in the evolving cell and gene therapy manufacturing landscape.
As both companies continue their respective development efforts, the outcomes of this evaluation will help shape future manufacturing strategies for TSC-101 and potentially set a precedent for how automated systems can be integrated into late-stage and commercial cell therapy production.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidate is in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA™ Phase 1 heme trial). The Company is also in early stages of developing methods for in vivo engineering to treat solid tumors. In addition, the Company is applying its target discovery platform to discover novel targets in various T cell-mediated autoimmune disorders.
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 drug sponsors 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. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes.
Cellares has achieved key clinical validation milestones, including a successful IND Amendment enabling active clinical manufacturing on the Cell Shuttle platform, and the successful dosing of first patients in a partner clinical trial — marking the platform’s transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.
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.
