352 Assessment of the Xiogenix Ares X20+ as an automated fill-finish solution for tumor-infiltrating lymphocyte therapy manufacturing
Year: 2026
Type: conference-abstract
Abstract: Background Cell therapy products are usually formulated in a cryoprotectant solution (CPS) and filled into cryo-containers prior to cryopreservation, a process that is often manual and time-consuming, especially for high cell yield drug products like tumor-infiltrating lymphocytes (TIL). Ideally, fill-finish should be consistent, controlled, and swift to help maintain integrity of the product and minimize DMSO-exposure time even when filling many containers, a challenge with manual operation even for skilled operators. The Ares X20+, a closed and automated fill-finish system developed by Xiogenix, addresses these challenges by improving process control, precision and efficiency. The Ares X20+ was evaluated in a series of runs at CTMC.Methods The Ares X20+ was calibrated for CTMC’s CPS and configured to run a range of fill-finish strategies and container types/sizes for TIL drug products. Likewise, a high throughput run using the Ares Extension Manifolds was performed for TR-56, CTMC’s proprietary TIL expansion reagent. The endpoints assessed were the fill accuracy & precision (post-fill and post-thaw) as well as the ability of the system to maintain product concentration, proliferation potential, and viability. Maintenance of TR-56’s functionality in supporting TIL growth was assessed as well. The Ares X20+ fill-finish process was compared to typical manual processes.Results The Ares X20+ filled a range of vials and bags within 5% of the target filling volume, including a high throughput run that generated 36 bags (target fill: 65 mL at 10x10 6 cells/mL). The average post-thaw volume and concentration recovered from Ares-filled bags showed superior process consistency compared to manually filled bags. TR-56 filled manually or using the Ares X20+ were functionally tested and demonstrated comparable ability to expand TIL. Finally, over the course of multiple fill-finish runs with TIL products from different donors/types of malignancies, the recovery & viability at thaw as well as after 48 hours in culture were similar between the automated and manual process.Conclusions The Ares X20+ offers improved process control and precision with less operator intervention compared to manual processes while preserving the product’s health and functionality. Its configurability and capacity position the Ares X20+ as a scalable solution for fill-finish of cellular therapy products.
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,490
OpenAlex ID: W7225156523