cTRL Therapeutics

Advancing cell therapy through automation

Impact

Circulating Tumor-Reactive Lymphocytes (cTRLs) represent a powerful new frontier in cancer immunotherapy. By enabling gentle, efficient isolation of these rare cells, the collaboration between cTRL Therapeutics and Key Tech is helping accelerate the development of transformative, scalable cancer treatments.

Scope

cTRL Therapeutics partnered with Key Tech to develop a cell processing platform — an instrument and consumable system that automates a proprietary step in their autologous therapy workflow. This innovation is helping cTRL translate a critical lab protocol into a scalable, clinical-ready process that supports IND submission and clinical trials.

Key Tech served as the primary developer of the cell processing platform, including:

• Instrument mechanical hardware, electronics, software, and enclosure
• Development and assembly of hundreds of sterile consumable prototypes
• Documentation and testing support for IND submission

cTRL Therapeutics owned workflow development, research, and regulatory strategy. Key Tech collaborated with cTRL’s CDMO partner to ensure usability and GMP compliance at every step.

Challenges

• Designing for sterility
  Key Tech engineered a fully closed, single-use consumable capable of maintaining sterility outside of a cleanroom, with gamma irradiation selected as the sterilization method.
• Achieving GMP compliance
  Consumables were designed for USP Class VI compatibility and full traceability. Software captured process metadata and incorporated operator access restrictions, while documentation supported GMP integration and IND preparation.
• Translating science into automation
  The platform replicated benchtop fluid pathways and flowrates, delivering comparable purity outcomes. Optical sensors and custom algorithms reduced dead volume and cell loss.
• Leveraging proven technologies
  By integrating off-the-shelf pumps, valves, sensors, and cleanroom-ready tablets, Key Tech minimized cost and accelerated development. The system’s software was built on Key#, Key Tech’s proprietary platform, customized to provide an intuitive interface for CMC engineers developing workflows as well as CDMO operators running processes — enabling speed, flexibility, and compliance.

Outcomes

• Built Alpha instruments and 50–70 consumables for process development
• Upgraded instruments for GMP compliance and in the process of building hundreds of consumables to support IND submission and clinical trials
• Developed optimized assembly methods to improve efficiency and scalability as demand grows

With cTRL Therapeutics, Key Tech helped bridge the gap between discovery and clinical application — accelerating the path of an innovative cell therapy platform toward patients in need.