CAR-T Cell Function Validation Services

Comprehensive CAR-T Cell Function Validation Services

Our CAR-T cell function validation service provides a rigorous preclinical assessment of your chimeric antigen receptor T-cell constructs, focusing on target specificity, cytotoxicity, cytokine release, and safety. We offer an integrated suite of in vitro co-culture assays, in vivo xenograft and humanized mouse models, and advanced imaging techniques to generate critical data that validate CAR-T cell performance before costly clinical development.

This service addresses the central challenge of CAR-T therapy development: ensuring that engineered T cells selectively eliminate tumor cells while minimizing off-tumor toxicity. Our assay portfolio evaluates killing kinetics, proliferation, cytokine profiles, and persistence in physiologically relevant tumor microenvironments. Ex vivo immunophenotyping of tumor-infiltrating lymphocytes can also be incorporated to understand CAR-T cell behavior at the single-cell level.

By combining clinically relevant in vitro and in vivo models with comprehensive analytics, our service enables efficient early evaluation of CAR-T agents, supporting IND-enabling studies and reducing translational risk.

Service Components

In Vitro Cytotoxicity & Potency Assays

Evaluate CAR-T cell killing efficiency against target-positive and target-negative cells using RTCA, LDH release, and flow cytometry-based assays. Assess proliferation and activation markers to confirm functional potency.

In Vivo Efficacy & Persistence Studies

Use bioluminescence imaging for non-invasive, longitudinal monitoring of tumor burden and CAR-T cell distribution in xenograft or humanized mouse models. Measure tumor growth inhibition, survival, and CAR-T persistence as scoped per project.

Comprehensive Immunophenotyping & Biomarker Analysis

Characterize the tumor immune microenvironment and CAR-T cell phenotype via multi-parameter flow cytometry, multiplex cytokine profiling, and immunohistochemistry to identify biomarkers of response and resistance.

Study Workflow

Project Scoping & Construct Review We collaborate with your team to define validation objectives, select appropriate target antigens, and review CAR construct design. This phase establishes the study parameters, including cell lines, donor T-cell sources, and assay endpoints.

In Vitro Functional Characterization Perform co-culture cytotoxicity assays with target-expressing and target-negative cells. Assess CAR-T cell proliferation, cytokine secretion (IFN-γ, IL-2, TNF-α), and activation markers (CD25, CD69) across multiple effector-to-target ratios.

In Vivo Efficacy & Safety Evaluation Inoculate tumor cells in immunodeficient or humanized mice, then administer CAR-T cells via intravenous or intratumoral routes. Monitor tumor growth by bioluminescence imaging and caliper measurements; collect blood and tissues for PK/PD analysis as scoped.

Data Analysis & Final Report Compile all study data including tumor growth curves, survival analysis, cytokine profiles, and histopathology. Provide a comprehensive report with statistical analysis and interpretation to support go/no-go decisions.

Service Scope & Deliverables

Parameter	Typical Project Scope
Target Cells	Client-provided or validated cell lines (e.g., tumor cell lines expressing the target antigen) or primary samples; scoped per project.
Effector Cells	CAR-T cells generated from healthy donor PBMCs or client-supplied CAR-T product; transduction verification included as scoped.
In Vitro Assays	Cytotoxicity (RTCA, LDH, flow cytometry), proliferation, cytokine release, and activation marker analysis; panel scoped per project.
In Vivo Model	NSG or humanized mouse models with tumor cells; group size, dosing schedule, and imaging endpoints scoped per project.
In Vivo Monitoring	Bioluminescence imaging, tumor volume measurements, body weight, clinical scoring, and optional PK/PD sampling.

Why Choose Our Service

Clinically Relevant Models

We provide access to a range of in vivo models, including patient-derived xenografts and humanized mice with a functional human immune system, enabling evaluation of CAR-T cell activity in a setting that mirrors human disease.

Advanced Imaging & Analytics

Bioluminescence imaging supports non-invasive, longitudinal tracking of tumor burden and CAR-T cell distribution, delivering real-time data on therapy efficacy and persistence as scoped per study.

Integrated In Vitro/In Vivo Platform

Our end-to-end service combines cell-based functional assays with animal models and multi-parameter immune profiling, generating a coherent dataset to support preclinical decision-making.

Experienced Immuno-Oncology Team

With years of experience in CAR-T development and immuno-oncology pharmacology, our scientists design robust studies and interpret complex data to address your specific validation questions.

Industry Perspective

Methods to monitor in vivo expansion and efficacy of CAR-T cells in preclinical models

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Ready to Validate Your CAR-T Therapy?

Contact our team to discuss your specific validation needs and design a customized study that de-risks your preclinical program.

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