Trenchant BioSystems Inc., a CGT manufacturing platform developer for gene-modified cells, has announced multiple internal and independent external data readouts for the prototype of its AutoCell CGT manufacturing platform.
Trenchant expects its AutoCell Platform will reduce CGT vein-to-vein timelines from its current industry-standard time of six weeks to 2.5 days through automated manufacturing and QC. The data demonstrate AutoCell platform can manufacture CGT with a sevenfold increase in gene-modified cell yield than existing technologies and reduce cost by up to 80%. Trenchant BioSystems data also show that AutoCell could make typical clinical doses and in-process and release testing with 25% of a fresh apheresis collection.
“The wider industry has run out of patience for the 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. Manufacturing is still too lengthy, labour intensive and costly to deliver CGTs to patients,” said Jon Ellis, CEO, Trenchant BioSystems.
Trenchant BioSystems has completed its internal validation process using five fresh apheresis sourced from healthy volunteer donors. These were processed in the Trenchant prototype within 36 hours of collection. The apheresis were washed using Trenchant wash buffer and Trenchant’s micro bubble protocol completed single step T cell selection and activation, prior to transduction with a GFP lentiviral vector. Trenchant said it has now achieved industry leading performance targets for washing, selection, and transduction unit operations with its prototype platform and processing cassettes. Additionally, the activation of T-cells demonstrates as controllable to ensure optimal levels of expression of CD25+ and CD69+ activation markers, key predictors of lentiviral transduction efficiency.
Trenchant also completed external validation of certain key data with Invetech, a global leader in solving complex manufacturing and product development challenges in the advanced therapies and diagnostics markets. Invetech’s testing demonstrated that the AutoCell platform can perform critical process steps (washing, selection, activation) with good process controls, providing a valuable validation of the platform’s core functionality.
The reduction in cell loss from the data showed that AutoCell could use whole blood a potential source material, not needing the more expensive, invasive and challenging apheresis. Trenchant BioSystems anticipates having a whole blood protocol completed and data release out in early Q2, 2026.
Trenchant BioSystems has also generated data demonstrating with CGT use outside CAR-T manufacturing, specifically with gene modified CD34+ cells for the treatment of hemoglobinopathies, genetic, and metabolic diseases. This extends the use of Trenchant BioSystems’ AutoCell for manufacturing of therapies for indications such as sickle cell, thalassemia or genetic diseases such as SCID. Trenchant BioSystems expects to complete a CD34 protocol and data release in late Q1 2026.
This will allow Trenchant BioSystems to advance to the productization of the AutoCell platform. This involves the development of the final and completed commercial platform and cassettes. Trenchant currently plans a first phase launch of an early access platform for select partners at the start of 2027, with full market access following in the first half of 2027.
“CGT manufacturing needs new, fully automated platforms that can realize the potential of these transformative therapies. Trenchant BioSystems confirmed through internal data that it had a promising solution to address these challenges. Invetech, through its own testing and assessment of the technology, sees tremendous potential in the Trenchant AutoCell solution,” said Andreas Knaack, CEO, Invetech.
CGT and specifically CAR-T manufacturing has been a major obstacle to widespread, affordable adoption for patients. Moves away from an unsustainable manual manufacturing model by the industry have met with limited success so far. Current approaches have limited automation, require highly trained operators, and suffer considerable cell loss through manufacturing processes.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.