CAR-T Toxicology - Creative Biolabs

To share our core scientific expertise and powerful platforms in cellular and gene therapies (CGT), Creative Biolabs is facilitated in this aim by our integrated cellular and gene therapy program. We are committed to preclinical development including CAR-T animal model, CAR-T pharmacology and CAR-T toxicology.

Our Objective

Creative Biolabs offers toxicological assessments of CGT cellular and gene therapy (CGT) products to achieve agencies’ approval in compliance with 21 CFR part 58, and careful considerations of the integrated program design will ensure efficient implementation. Both scientific and regulatory concerns will be considered via a strategy and consultation-based approach. Our multidisciplinary team will customize the services to fit novel properties of your CGT products, such as complications of cross-species reactivity.

Toxicology Studies

We are able to perform various toxicological studies to evaluate potential safety risks in animal models and predict potential safety risks for humans prior to exposure to humans via body weight, biomarker analysis, feed consumption measurements, preclinical pathology evaluations, organ weight, and histopathology assessments. Immunogenicity concerns and irreversibility of engraftment will be conducted, while systemic toxicity might be less of concern for CGT products. For individual toxicology studies, please visit the following buttons to learn more.

General Toxicology

Genetic Toxicology

Immunogenicity

Developmental and Reproductive Toxicology

Potency and Dose Response

Neurovirulence Safety Testing

Toxicology measurements

To assess the toxicology, we can perform various assays to monitor the following biomarkers or endpoints.


✔ Administration site reactions	✔ Inflammatory response	✔ Host immune response
✔ Migration away from administration site	✔ Ectopic tissue formation	✔ Abnormal proliferation
✔ Tumorigenicity	✔ Toxicity types, frequencies, and severity	✔ Toxicity risk analysis: Potential clinical toxicities, projected risks, organ(s) affected, and indicators

Considerations for toxicology studies

Our toxicology study program will determine the effective dose levels, escalation and overall regimen based on the following considerations.

Adequate numbers and randomization;
Appropriate controls;
Bracketed dosing;
Dosing schedule modeled on clinical protocol;
Clinical route of administration;
Including delivery device where applicable;
Assessments for standard acute and chronic effects;
Assessments for product specific expected toxicities.

With senior scientists of preclinical toxicology and comprehensive animal models, Creative Biolabs can assist in conducting the most appropriate integrated toxicological studies, evaluating the safety data, and helping our clients to develop better cellular and gene therapy products. For more detailed information, please visit our website or contact us directly.

For Research Use Only | Not For Clinical Use