Work

341 SMART G-Rex® & SensoRexTM technology for in-line, non-invasive, and real-time monitoring of TIL expansion

Year: 2026

Type: conference-abstract

Abstract: Background The expansion of Tumor-Infiltrating Lymphocytes (TIL) from tumor samples is highly variable across individual tumors and malignancy types. To simplify manufacturing, minimize manipulations, and time spent in a GMP suit, most TIL programs rely on fixed harvest times. However, this approach may lead to TIL undergrowth or overgrowth and, in turn, negatively affect in vivo growth potential after infusion. Simple and reliable monitoring of cell expansion could better inform growth kinetics and influence harvest timing, potentially enabling greater process consistency and flexibility to improve product quality. Conventional approaches rely on manual sampling, which can disturb culture conditions, increase contamination risk, and increase hands-on time, while only providing limited snapshots of growth. SMART G-Rex and SensoRexTM comprise a novel and integrated process analytic technology (PAT) which enables in-line, real-time, and non-invasive measurements of TIL expansion within a fully closed system.Methods For the first phase of expansion, the pre-Rapid Expansion Protocol (pre-REP) phase, previously processed and cryopreserved tumor fragments were thawed and cultured in a closed-system SMART G-Rex100M-TF. TIL were expanded using CTMC’s pre-REP TIL expansion platform method. Within one week of culture initiation, TIL growth was monitored using traditional methods (visual assessment and glucose analysis) and compared with the SensoRex’s resonant frequency reading of the SMART G-Rex100M-TF. For the REP, cultures were initiated in a transitional G-Rex100M for the first week, followed by a split into a SMART G-Rex 100M-TF for the second week. SMART G-Rex® readings were taken daily during the second week. Parallel reference measurements, including glucose levels and viable cell counts, were used to compare SMART G-Rex® measurements with conventional culture monitoring approaches.Results SMART G-Rex® and SensoRex® technology enabled non-invasive monitoring of cell growth throughout TIL manufacturing phases. Growth trends measured by the SMART G-Rex revealed high variability in growth patterns across different TIL lines derived from different tumor types, supporting the use of integrated PAT to guide data-driven harvest decisions. SMART G-Rex technology improved the manufacturing process by reducing reliance on subjective visual assessment and showed superiority compared with glucose assessment, rendering culture sampling an obsolete process.Conclusions SMART G-Rex® technology enabled sampling-free tracking of TIL expansion, generating growth curves that reflect both cell growth kinetics and culture quality throughout manufacturing. Even with predefined harvest times, this approach could meaningfully reduce the risk and cost associated with manual sampling in GMP manufacturing and provide real-time quality assurance of the drug substance throughout manufacturing.

Source: Journal for ImmunoTherapy of Cancer

DOI: 10.1136/jitc-2026-sitc2026.0341