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CAR-T Testing Services

Chimeric antigen receptor (CAR)-T therapy is a type of immunotherapy that presents diverse opportunities for advancing cancer treatments, especially hematologic malignancies like acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL). Our comprehensive testing services for CAR-T therapies cover the entire spectrum of novel drug development, from discovery to IND to NDA.

Comprehensive Preclinical
Testing for CAR-T Drugs

CAR-T therapy in solid tumors shows promise for further innovation. However, researchers face challenges related to the solid tumor microenvironment and antigen variability. With capabilities in safety assessment, DMPK/ADME, bioanalysis, pharmacology, and CMC, WuXi AppTec can help you meet these challenges with CAR-T development – all conveniently under one roof.


Leverage a global network of facilities offering a full range of discovery screening, preclinical development, and clinical drug metabolism and pharmacokinetic services.


Put your CAR-T program on the right track with a bioanalytical strategy designed to establish and execute the right assays for regulatory submission.


Our integrated safety assessment services provide multidisciplinary expertise and experience that saves time and cost while yielding the valuable data you need.


We support your CMC authoring needs, in both the US and China, from preclinical to commercial lifecycle management for both drug substance and product.


Get validated discovery assays, including in vitro assays and in vivo disease models in cardiovascular, CNS, respiratory, metabolic, and infectious diseases.

Regulatory Affairs

Make global filings convenient, efficient, and cost-effective across US FDA, NMPA, and EMA with our extensive regulatory submission support.

End-to-End Preclinical Services

WuXi AppTec offers a comprehensive testing platform for CAR-T therapies, including bioanalysis, biomarker analysis, in vitro and in vivo assays, and immunophenotyping.

Custom Study Strategies

Our team specializes in designing customized study strategies for CAR-T therapies, integrating insights from DMPK, bioanalysis, and safety assessment. We offer rapid optimization and timely adjustments, leveraging flexible study concepts to meet evolving project needs. Our approach ensures comprehensive support throughout the preclinical development process, enabling efficient advancement of CAR-T therapeutics.

Global Partner & Network

WuXi AppTec is a true global provider in preclinical services, with state-of-the-art facilities, instrumentation, and experts across US, Europe and China. We have decades of experience operating within diverse regulatory environments and delivering tailored testing solutions that advance peptides from preclinical through IND, NDA and beyond.

Frequently Asked Questions

What are CAR-T therapies?

CAR-T therapies are a form of immunotherapy where T cells are modified to express a Chimeric Antigen Receptor (CAR) that targets cancer cells. CAR-T therapies modify a patient’s T cells to express receptors that specifically recognize and bind to antigens on cancer cells, leading to their destruction. This personalized immunotherapy is designed to enhance the body’s natural immune response against cancer.

Why is preclinical testing important for CAR-T therapies?

Preclinical testing is crucial for CAR-T therapies to ensure safety and efficacy before advancing to clinical trials. It helps identify potential toxicities, optimize dosing regimens, and assess the therapy’s ability to target and eliminate cancer cells. This stage of testing is essential for uncovering any off-target effects, understanding the potential for cytokine release syndrome (CRS), and evaluating the overall pharmacokinetic and pharmacodynamic profiles. By thoroughly investigating these factors in preclinical models, researchers can mitigate risks, refine the therapeutic approach, and enhance the likelihood of successful outcomes in subsequent clinical trials.

What types of safety assessments are conducted during preclinical testing?

These assessments typically include evaluating toxicity to determine harmful effects on organs and tissues, investigating off-target effects to ensure specificity and avoid unintended side effects, and assessing the potential for cytokine release syndrome (CRS), a severe inflammatory response. Additionally, studies are conducted to evaluate tumorigenicity and oncogenicity risks, immunogenicity to understand the immune response against CAR-T cells, and pharmacokinetics and pharmacodynamics (PK/PD) to study the behavior and activity of CAR-T cells in the body. Genomic integration site analysis is also performed to ensure genetic modifications do not disrupt critical genes, ensuring the overall safety of the therapy.

What efficacy endpoints are typically evaluated in preclinical studies of CAR-T therapies?

Efficacy endpoints often include tumor regression, survival rates, and the ability of CAR-T cells to target and kill cancer cells without harming normal cells.

How is the immune response to CAR-T cells assessed in preclinical models?

The immune response is assessed by measuring cytokine production, immune cell infiltration, and the activation status of CAR-T cells.

How is the dosage of CAR-T cells determined during preclinical testing?

Dosage is determined by assessing the optimal number of CAR-T cells needed to achieve desired therapeutic effects without causing significant toxicity.

What regulatory guidelines must be followed during preclinical testing of CAR-T therapies?

Preclinical testing must follow guidelines set by regulatory agencies like the FDA and EMA, which include Good Laboratory Practice (GLP) standards.

How is the persistence of CAR-T cells evaluated in preclinical studies?

Persistence is evaluated by tracking the presence and activity of CAR-T cells over time using molecular and cellular assays. These include techniques in flow cytometry, quantitative PCR, bioluminescence imaging, cytokine analysis, and histological examination.

What types of studies are essential in the preclinical testing of CAR-T therapies?

Preclinical testing of CAR-T therapies involves several key studies. In vitro studies assess the ability of CAR-T cells to kill cancer cells, proliferate, activate, and release cytokines. In vivo studies use animal models to test the effectiveness, distribution, and persistence of CAR-T cells in the body. Safety and toxicology studies evaluate potential off-target effects, determine safe dose ranges, and assess the risk of immune reactions against the CAR-T cells. These studies provide essential data on the safety and effectiveness of CAR-T therapies, helping to design and guide clinical trials.

Let’s Talk About Your CAR-T Therapy Program

Have questions? Need specific assays? Talk to an expert today about your CAR-T therapeutic needs.