Automated CAR-T Manufacturing for Decentralised Therapy

Personalised CAR-T cell therapy requires complex, multi-step processing of patient-specific immune cells. Fraunhofer Institute for Manufacturing Engineering and Automation IPA and Festo are collaborating to automate this workflow using modular, cassette-based systems designed for decentralised deployment in clinical settings.

Context of the Cooperation
CAR-T therapies involve extracting, modifying, and reinfusing a patient’s T cells to target cancer cells. Despite clinical effectiveness, adoption remains limited due to manual processing, high costs, and stringent cleanroom requirements.

Fraunhofer IPA contributes expertise in production system design and biomedical process engineering, while Festo provides industrial automation technologies, including fluid control and actuation systems. The cooperation addresses the need for scalable, repeatable manufacturing processes that can operate outside large centralised facilities.

The approach aligns with broader trends in industrial automation applied to life sciences, where reproducibility and process control are critical for regulatory compliance and therapeutic consistency.

Technical Solution and Responsibilities
The partners have developed a modular “mini-factory” architecture composed of process modules linked by patient-specific cassettes. Each cassette contains a closed, sterile fluidic system for a single therapy step, reducing cross-contamination risks.

Fraunhofer IPA defines the system architecture and process sequencing, while Festo integrates automation components for fluid handling. A key element is the diffusion bonded manifold, which enables compact and leak-tight fluid routing within the cassette.

This manifold integrates microchannels and valve interfaces, allowing external pneumatic control without direct contact with the biological material. Fluid transport is achieved using compressed air and vacuum, enabling precise dosing and mixing of media in microlitre-scale volumes.

Temperature control and media exchange within the cell culture chamber ensure stable conditions for viral transduction, where genetic material encoding chimeric antigen receptors is introduced into T cells.

Deployment and Implementation
The system is designed for decentralised installation, such as in university hospitals or specialised treatment centres. Modular integration allows stepwise deployment, with each unit handling defined stages of the therapy process.

The cassette-based approach separates disposable, patient-contact components from reusable hardware. Only fluid-contact elements require replacement, enabling maintenance outside cleanroom environments and reducing operational complexity.

Demonstrations of the cassette and module interaction were presented at Hannover Messe 2026, highlighting integration between mechanical handling, pneumatic control, and sterile processing.

Applications and Use Cases
The system targets oncology applications requiring personalised immunotherapy. Use cases include:

By enabling decentralised production, the approach supports faster therapy turnaround and reduces logistical constraints associated with central manufacturing.

Results and Expected Impact
Automation reduces manual intervention, improving process repeatability and lowering the risk of human error. The compact manifold design enables precise fluid control within limited space, supporting high-density system layouts.

Operationally, decentralised mini-factories reduce transport times for patient material and enable parallel processing of multiple therapies. Cost reductions are achieved through lower labour requirements and simplified infrastructure.

Overall, the cooperation demonstrates how modular automation can translate complex biotechnological processes into scalable, clinically deployable systems, improving accessibility of personalised cancer treatments.

Edited by an industrial journalist Sucithra Mani with AI assistance.

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