CAR-T Testing Solutions

AR-T and NK cell therapies are among the most clinically advanced and commercially mature forms of cell therapy. Xuzhenda Biotech has extensive experience in CAR vector copy number analysis, lentiviral vector integration site analysis, and on-target/off-target assessment for gene editing. Backed by extensive project experience and well-established service workflows, we provide comprehensive analytical solutions for immune cell therapy development.To support the development of next-generation cell therapies, we also offer customized services, including single-cell vector copy number analysis, cytokine and immune biomarker profiling, and single-cell phenotypic and gene expression analysis. Our analytical solutions are designed to meet the quality requirements for clinical trials and regulatory submissions.We have collaborated with leading industry partners on multiple investigator-initiated trials (IITs) and registrational clinical studies, supported numerous IND and NDA submissions, and completed testing for thousands of clinical samples.

CAR-T/NK Solutions

Project Experience

Advantages

Analysis of Genomic Insertion Sites of Integrated Vector

A mature, extensively validated detection workflow and a comprehensive analysis report covering genomic distribution of integration sites, integration site sequence preference analysis, enrichment analysis of tumor-associated gene insertion sites, and other key metrics. In addition to lentiviral vectors, this solution is also applicable to transposon vectors and other genomic integration vectors.

 Highly Sensitive Multiplex Immune Profiling

The high-sensitivity proteomic profiling solution enables simultaneous detection of over 11,000 protein markers, covering key signaling pathways. Among these, the multiplex immune and inflammatory cytokine assay enables absolute quantification of 5, 30, 45, or 150 cytokines with sensitivity down to fg/mL levels. This solution supports preclinical pharmacology, pharmacodynamics, and toxicology studies in cellular and animal models, as well as immune marker profiling of clinical trial samples before and after treatment to evaluate drug efficacy and safety.

Multiplex Absolute Quantification of Cytokines

Immunological Profiling and Clone Tracing

Comprehensively characterize immune cell diversity, clonal expansion dynamics, and V(D)J rearrangement profiles at both single-cell and population levels; identify and track changes in disease-associated clones across different treatment stages, evaluate immune reset effects, and investigate the mechanisms of action of immunotherapies. Xuzhenda provides a range of immune repertoire analysis solutions tailored to diverse clinical scenarios. The methodology has been rigorously validated, supported by extensive experience in clinical trial sample testing.