Trenchant BioSystems has released internal and external data confirming its AutoCell prototype platform can dramatically reduce manufacturing times for cell and gene therapies (CGT) while increasing yield and lowering costs. The platform, designed for gene-modified cells, is reported to cut vein-to-vein timelines from the industry-standard six weeks to just 2.5 days and increase gene-modified cell yield sevenfold.

Internal validation used fresh apheresis from healthy donors, processed within 36 hours, and tested key unit operations including washing, T-cell selection, activation, and transduction with a GFP lentiviral vector. The platform achieved industry-leading performance across these steps, demonstrating controllable activation of CD25+ and CD69+ markers, key predictors of transduction efficiency. Trenchant also reported the process could generate clinical doses using only 25% of a fresh apheresis collection, potentially reducing reliance on invasive apheresis procedures.

External validation with Invetech, a provider of manufacturing and product development solutions in advanced therapies, confirmed the platform’s ability to perform critical process steps with effective process controls. Andreas Knaack, ceo of Invetech, said: “Invetech, through its own testing and assessment of the technology, sees tremendous potential in the Trenchant AutoCell solution.”

Jon Ellis, CEO of Trenchant BioSystems, said: “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. 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%.”

Beyond CAR-T manufacturing, Trenchant has generated data using gene-modified CD34+ cells for hemoglobinopathies, genetic, and metabolic disorders, including sickle cell, thalassemia, and SCID. The company plans to complete a CD34 protocol in late Q1 2026, and a whole blood processing protocol by early Q2 2026.

Trenchant BioSystems aims to productize AutoCell with a first-phase early access launch for select partners in early 2027, followed by full commercial access in the first half of 2027. The platform is positioned as a fully automated solution to the longstanding challenges of CGT manufacturing, which has traditionally relied on labour-intensive processes with high cell loss.