Nonclinical Safety and Toxicity Testing
The development of pharmaceuticals, including mRNA vaccines, is a stepwise process. The process can be divided into nonclinical and clinical. Nonclinical testing is a prerequisite to moving a candidate vaccine from the laboratory to the clinic, involving product characterization, potency testing, safety testing and so on. Creative Biogene is a dedicated provider of mRNA-based drug R&D services. Besides mRNA vaccine characterization and potency testing services, we also offer nonclinical safety and toxicity testing service for mRNA vaccine development. We are committed to accelerating vaccine development for our global customers.
Why conduct nonclinical safety and toxicity testing?
During pharmaceutical development, safety/toxicological testing is quite a regulated and complex process. In general, testing goals include characterizing toxic effects on target organs, dose dependence, and relationship to exposure. Although nonclinical safety/toxicological testing is limited in clinical development, the information provided in these studies is essential and useful at the beginning of clinical development, determining parameters for clinical monitoring, such as initial safe starting dose, the optimum dose and dose range for the clinical trials.
For vaccine development, safety/toxicological testing is an essential as well as complex step. The testing is typically performed in animal models. A large number of animals and relevant facilities are required. Besides, the testing process is relatively lengthy. There are situations where toxicity increases with treatment duration or the toxic symptoms are persistent. Creative Biogene offers a one-stop service tailored to our customer's needs to help solve the unexpected.
We follow the WHO guidelines for using gene therapy products when designing testing strategies for mRNA vaccines. We begin with the following procedures: learning the vaccine's characteristics, the purpose of intended clinical use, and the selection of the adequate animal model. Moreover, the potential toxic effects of mRNA vaccine will be assessed with route(s) of exposure, target organs, using dose, and monitoring indices. Importantly, the study designs obey the characteristics of the specific mRNA vaccine.
- Single dose toxicity
- Repeated dose toxicity
- Bio-distribution measurement
- Safety pharmacology
- Local tolerance
- Immunogenicity studies
Creative Biogene is passionate about strong customer orientation and high-quality service. We are committed to providing adequate preclinical safety/toxicological testing service for mRNA vaccines to facilitate successfully proceed to clinical investigation. Please don't hesitate to contact us for more service details! We are looking forward to serving you!
- Hager, G. (2017). "Nonclinical Safety Testing of RNA Vaccines. In RNA Vaccines (pp. 253-272)." Humana Press, New York, NY.
- Green, M. D., & Al-Humadi, N. H. (2017). "Preclinical Toxicology of Vaccines." A Comprehensive Guide to Toxicology in Nonclinical Drug Development, 709-735.