Trenchant BioSystems has announced significant advancements in its AutoCell CGT manufacturing platform, showcasing multiple internal and independent external data readouts. The company aims to dramatically shorten the vein-to-vein timelines for cell and gene therapies (CGTs) from the current industry standard of six weeks to just 2.5 days through automated manufacturing and quality control processes.
According to Jon Ellis, CEO of Trenchant BioSystems, the data indicates that the AutoCell platform can achieve a seven-fold increase in gene-modified cell yield compared to existing technologies. Additionally, it has the potential to reduce manufacturing costs by up to 80%. Ellis emphasized that the platform could produce typical clinical doses and conduct in-process and release testing with only 25% of a fresh apheresis collection.
Challenges in Current CGT Manufacturing
Ellis highlighted the pressing need for more efficient manufacturing practices within the CGT industry. He stated, “The wider industry has run out of patience for cell and gene therapy to deliver manufacturing practices resulting in therapies to large-scale patient populations in an affordable manner. To date, this is still theoretically, but not practically, possible.” He noted that the current manufacturing methods are too lengthy, labor-intensive, and costly to effectively deliver CGTs to patients.
The data suggests that the AutoCell platform could be a game-changer, potentially allowing CGTs to be administered as first-line therapies. Trenchant BioSystems has completed its internal validation process using five fresh apheresis sourced from healthy volunteer donors, processed within 36 hours of collection. This process utilized Trenchant wash buffer and the company’s micro bubble protocol to complete single-step T cell selection and activation before transduction with a GFP lentiviral vector.
Validation and Future Prospects
The company has achieved its performance targets for washing, selection, and transduction operations with the prototype platform and processing cassettes. Ellis noted that the activation of T cells is controllable, allowing for optimal levels of expression of CD25+ and CD69+ activation markers, which are critical predictors of lentiviral transduction efficiency.
Trenchant also completed external validation with Invetech, a firm specializing in customizable platform solutions. Invetech’s testing confirmed that the AutoCell platform can effectively perform essential process steps such as washing, selection, and activation with reliable process controls. Ellis stated that this validation is crucial for affirming the platform’s core functionality.
The proprietary technologies utilized in the CGT manufacturing process aim to eliminate the costly and time-consuming ex vivo expansion of CAR-T cells required to produce a clinical dose. Ellis further explained that the reduction in cell loss indicated that the AutoCell could utilize whole blood as a potential source material, thereby avoiding the more expensive and invasive apheresis method.
Trenchant BioSystems is on track to complete its whole blood protocol and anticipates releasing additional data in early Q2 2026. This innovation could mark a significant step forward in making CGTs more accessible and affordable for patients in need.
