Trenchant BioSystems release internal and external, independent data of its AutoCell™ prototype manufacturing platform, confirming CGT industry leading performance claims
Data shows reduction of CGT manufacturing times to 2.5 days, extension from CAR-T and considerable cost reductions from current CGT manufacturing practices
Sacramento, California, US, January 9, 2026
Trenchant BioSystems Inc., the CGT manufacturing platform developer for gene-modified cells, today announces multiple internal and independent external data readouts for the prototype of its AutoCell CGT manufacturing platform.
Trenchant expects their AutoCell Platform will reduce CGT vein-to-vein timelines from its current industry-standard time of 6 weeks to just 2.5 days through automated manufacturing and QC. This data demonstrates AutoCell platform can manufacture CGT with a 7-fold increase in gene- modified cell yield than existing technologies and reduce cost by up to 80%. Trenchant BioSystems data also demonstrates 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, labor intensive and costly to deliver CGTs to patients,” said Jon Ellis, CEO, Trenchant BioSystems. “Trenchant has now confirmed with internal and external data that its manufacturing platform can reduce both manufacturing timelines to 2.5 days, and costs by over 80%. This could pave the way for CGTs for the first time as first-line therapies. Now Trenchant BioSystems has confirmed this with Invetech, we look forward to working more closely together in the future. Trenchant will remain focused on delivering our transformative technology to the CGT sector.”
Trenchant BioSystems has completed its internal validation process using 5 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 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 additionally 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 successfully 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.
These combined data confirm an accumulated cell processing efficiency across all washing, selection, activation and transduction steps that is a remarkable 7-fold improvement over current practices. Their CGT manufacturing process uses proprietary technologies, to remove the current requirement of costly and lengthy ex-vivo expansion of CAR-T cells to produce a clinical dose.
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 data 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.
About Trenchant BioSystems
Trenchant BioSystems is a leading disruptive firm reimagining cell and gene therapy manufacturing to be scalable, efficient, rapid and affordable through the development of truly end to end manufacturing platforms. Trenchant has developed a manufacturing modality that will reduce the production times for CAR-Ts to 2.5 days. Its manufacturing processes also reduce CAR-T manufacturing cost significantly. Trenchant was launched in 2022, and is based in Sacramento, CA, US. It was founded by chairman and CTO Philip Coelho, CEO Jon Ellis, and Bill Busa, PhD. To discover more about Trenchant, visit https://www.trenchantbio.com.
For more information contact:
Neil Hunter
Hunter PR
neil@hunterpr.biz
+44 7821 255568