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Cell and Gene Therapy
T-Track 
TILs Product Quality Assessment & PK Monitoring Solutions
Solutions for Multi-omic Drug Quality and Safety Research
Tumor-infiltrating lymphocyte (TIL) therapy is a form of adoptive cellular immunotherapy in which autologous T cells are isolated from a patient's tumor tissue, expanded ex vivo, and reinfused into the patient to mediate antitumor immune responses. According to current FDA and EMA guidelines, T-cell receptor (TCR) clonotype analysis can be used to evaluate TIL product quality and manufacturing process consistency. It is recognized as a key critical quality attribute (CQA) and is expected to become an important component of product release testing for TIL therapies.
Services
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T-Track TILs Product Quality Assessment – Patient TCR Clonotype Profiling
* Assessment of T-cell receptor (TCR) clonotype diversity in patient tumor tissue
T-Track TILs Product Quality Assessment – Evaluation of TCR Clonotype Diversity Changes in Expanded TIL Products
* Assessment of T-cell receptor (TCR) clonotype diversity in tumor-infiltrating lymphocyte (TIL) products
* Comparison with the TCR clonotype diversity of the patient's tumor tissue to evaluate dynamic changes during TIL expansion
* Evaluation of product quality and manufacturing process consistency
T-Track TIL Therapy Pharmacokinetic (PK) Assessment – TCR Clonotype Diversity Monitoring
* Monitoring dynamic changes in T-cell receptor (TCR) clonotype diversity in peripheral blood following TIL product infusion
* Evaluation of in vivo persistence, expansion, and immune reconstitution following TIL therapy
Note: Methodology has been verified
Advantages
Cases
End-to-end clonotype tracking and in vitro/in vivo kinetic monitoring for TIL products.
TIL therapy has demonstrated remarkable efficacy in melanoma; however, clinical responses remain highly heterogeneous among patients. Traditional cell product quality attributes, such as cell count and viability, have limited predictive value for clinical outcomes. A major challenge is the inability to accurately identify tumor-resident T-cell clones with genuine antitumor activity.By longitudinally tracking millions of TCR clonotypes throughout treatment—from the baseline tumor (T0), to the ACT product, and to post-infusion tumor samples (T30)—TCR sequencing enables:
Source identification: Quantification of the proportions of tumor-resident and blood-derived clonotypes.
Expansion efficiency assessment: Evaluation of the expansion and enrichment of tumor-specific clonotypes during ex vivo culture.
In vivo pharmacokinetic (PK) monitoring: Quantitative tracking of the persistence of reinfused clonotypes and their homing efficiency to tumor lesions, providing biomarkers for predicting clinical response.
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