Trenchant BioSystems and Autolomous to Combine Platforms for Automated CGT Manufacturing

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UK-based Autolomous, a cloud-based, cell and gene therapy (CGT) software platform developer, announced on Jan. 20, 2025 that it has partnered with US-based Trenchant BioSystems, a CGT manufacturing platform developer for gene-modified cells, to combine technology platforms to address timelines, costs, and challenges with CGT manufacturing.

Under the partnership, Trenchant will integrate Autolomous’ autoloMATE digital solution into their automated CGT manufacturing platform, which has been designed for distributed manufacturing at appropriate global medical facilities. The collaboration is aimed at delivering the first manufacturing process to the market encompassed in a single compact, fully automated chassis combined with a digital platform that generates automated batch records while capturing manufacturing performance and lot-release data in real time.

“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, in a company press release (1). “Trenchant has developed a manufacturing platform that can reduce both manufacturing timelines to 2.5 days, and costs by over 80%. 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.”

Trenchant is currently validating an Alpha Prototype of its platform, which the company said takes a fresh approach to CGT manufacturing. The prototype delivers an accumulated cell processing efficiency across all washing, selection, activation, and transduction steps that results in an eight-fold improvement over current practices. The company’s CGT manufacturing process involves a proprietary cell selection and activation technology, spinoculation, and cell washing technologies that remove the current requirement of ex-vivo expansion of chimeric antigen receptor T (CAR-T) cells, which is a costly and lengthy process to produce clinical doses (2).

Trenchant’s platform was designed with digital integration at its core which is meant to reduce the duration of CAR-T manufacturing and lower the cost of goods and labor, both of which have been barriers to patient access. Autolomous offers its expertise in delivering solutions for the CGT space across an international user base that includes academics, contract development and manufacturing organizations, and biotechs. Trenchant selected Autolomous for this advantage as well as Autolomous’ extensive experience in integrating with systems and devices.

Trenchant expects to release internal performance data on the integrated platforms in the first quarter of 2025, after which data generated by a third party currently manufacturing CAR-T cells for clinical use will be released. Trenchant plans to offer its early access programs by the end of the third quarter of 2026.

“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, in the press release. “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.”

References

1. Autolomous. Trenchant BioSystems and Autolomous Partner to Integrate Automated Cell and Gene Therapy Manufacturing and Digital Solutions. Press Release. Jan. 20, 2025.
2. Cliff, E. R. S.; Kelkar, A. H.; Russler-Germain, D. A.; et al., High Cost of Chimeric Antigen Receptor T-Cells: Challenges and Solutions. Am Soc Clin Oncol Educ Book 2023, 43, e397912. DOI:10.1200/EDBK_397912