Trenchant BioSystems Inc., the CGT manufacturing platform developer for gene-modified cells, and Autolomous, the cloud-based, cell and gene therapy (CGT) software platform developer, today announce their platforms will be combined under the terms of a long-term partnership agreement that will address the timelines, costs and challenges within the CGT manufacturing sector.
As a result of the partnership, Trenchant BioSystems will integrate Autolomous’ autoloMATE digital solution into their automated CGT manufacturing platform that has been designed for distributed manufacturing at competent medical facilities globally. This will deliver to the market the first manufacturing process in a single, compact chassis and fully automated, combined with a digital platform that automates batch records and captures manufacturing performance and lot-release data in real time.
Trenchant is in the process of validating the Alpha Prototype of its platform that takes a fresh approach to CGT manufacturing. This delivers an accumulated cell processing efficiency across all washing, selection, activation and transduction steps that is a remarkable 8-fold improvement over current practices. Their CGT manufacturing process uses a proprietary cell selection and activation technology, spinoculation, and cell washing technologies to remove the current requirement of costly and lengthy ex-vivo expansion of CAR-T cells to produce a clinical dose.
Trenchant has designed its platform with digital integration at its core to reduce the duration of CAR-T manufacturing as well as lower cost of goods and labor which are barriers to patient access. Trenchant selected Autolomous for its expertise in delivering solutions for the CGT space across a diverse and international user base – academics, CDMOs and biotechs, as well as their extensive experience integrating with systems and devices.
Trenchant expects to release internal performance data in Q1 2025, followed by data generated by a third party currently manufacturing CAR-T cells for clinical use. Trenchant currently aims to offer their early-access programs by the end of Q3 2026.
“The use of current cell and gene therapy manufacturing practices to deliver therapies to large-scale patient populations in an affordable manner is currently theoretically, but not practically, possible. Without significant changes, manufacturing is too lengthy, labor intensive and costly to deliver CGTs to patients,” said Jon Ellis, CEO, Trenchant BioSystems. “Trenchant has developed a manufacturing platform that can reduce both manufacturing timelines to 2.5 days, and costs by over 80 percent. This can place CGTs for the first time as first-line therapies. To integrate digitalization into this development is critical, and this is why we have selected Autolomous’ autoloMATE as the most advanced CGT-specific digital platform to enable this transformation for the CGT marketplace.”
“Current costs of CGTs, and CAR-Ts specifically, are way beyond the resources of societies to pay for them. Significant highly qualified labor is required to manufacture, review, and release each CAR-T batch. As a result, digitization is essential for CGTs to realistically realize their dramatic therapeutic potential to provide new solutions for a range of patients with no alternative therapeutic options,” said Alexander Seyf, CEO, Autolomous. “Trenchant has now devised a new CAR-T manufacturing modality in its own right that will alter the way CGTs are created. This is why Autolomous has entered a partnership agreement with Trenchant to ensure therapies reach unprecedented patient numbers.”
