To bring cutting-edge viral therapies to market efficiently, you need a nonclinical research partner who can go beyond the basics. Working with live viruses requires specialized expertise and laboratory capabilities. You’ll find everything you need for successful nonclinical trials of oncolytic viral therapies at Battelle, including BSL3 facilities and laboratory staff with experience in working with infectious agents and non-standard regulatory pathways.
Oncolytic viral therapies—which use live, genetically modified viruses to target cancer cells—are among today’s most promising emerging cancer treatments. They must go through the same regulatory pathways as any other drug or therapy to get to market. Battelle provides comprehensive nonclinical services to help bring innovative viral therapies to market quickly and successfully.
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- Nonclinical in vivo and in vitro research to evaluate the safety and efficacy of viral therapy candidates and determine which candidates should move forward
- Toxicology for candidate viral therapies
- Required preclinical studies for regulatory submission and FDA approval of new therapies
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Battelle brings together a unique set of capabilities and expertise for nonclinical studies of oncolytic viral therapies.
Infectious Agent Readiness
- Laboratory staff have received hard-to-obtain vaccinations for many of the viruses used in viral therapies
- BSL2 and BSL3 laboratory capabilities
- Decades of experience with highly dangerous and infectious agents, including biosecurity work and vaccine research
Nonclinical Research Capabilities
- In vivo and in vitro capabilities for most common toxicology endpoints, including neurobehavioral, neuro-virulence, cardiopulmonary, development and reproductive (DART), clinical and anatomic pathology
- Analytical capabilities including ELISA, qPCR, cytokine/ chemokine analysis, antibody response, TCID50/infectivity assay and others to evaluate biodistribution, shedding and immunology parameters
- Experience working with innovative therapies, including viral, biologic and small molecule
- Unique staff expertise in a range of related disciplines, including virology and cancer biology
- Decades of experience in regulatory processes and a strong track record assisting clients with successful submission
- Fully trained in GLP procedures and documentation
- Experience in navigating alternate regulatory pathways for non-standard therapies
Battelle has been working with viral therapies since 2013. We can help you design an efficient nonclinical research program for your oncolytic viral therapy, so you can move forward with confidence and get innovative treatments to market sooner. You’ll have access to our top experts every step of the way. We will work with you to ensure that your program is set up for success and you can proceed to the next step (clinical trials) as efficiently as possible.