Pre-clinical Toxicology of Cancer Vaccines

All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

Cancer vaccines have been widely recognized as one of the greatest achievements in cancer prevention due to their high effectiveness in preventing morbidity and mortality. Creative Biolabs is dedicated to pre-clinical development for cancer vaccine including animal models for vaccine, pre-clinical pharmacology for vaccine and pre-clinical toxicology of vaccines.

Our Pre-clinical Toxicology Services

Creative Biolabs has a wide range of services and expertise to help vaccine developers to develop a comprehensive strategy covering pre-clinical development to clinical trials. Toxicological assessments of multiple species can be designed, performed, and documented through wide range routes of administration. Our toxicological studies offer insights into safety data required for vaccine development. In order to meet the requirements of preclinical surveillance in a GLP compliant environment, we offer CDC-approved quarantine facilities with Biosafety Level (BSL)-2.

In Vivo Toxicology Studies

For autologous DC vaccines, human HLA specific therapies, etc., to get a better understanding about the information of the antigen, construct, expression and tissue distribution, etc., we offer a variety of studies including mRNA expression, tissue cross-reactivity studies of mAb against the Ag and genomic database searching. For individual toxicological studies, please visit the following buttons to learn more.

Tissue Cross-Reactivity Studies

Performed prior to human exposure for novel antigens potentially expressed in normal tissues;
Determine tissue binding using appropriate immunohistochemical procedures;
Analogous study in preliminary pre-clinical toxic species may help confirm the species correlation of animal models.

Toxicological Measurements

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

Administration site reactions
Migration away from the administration site
Tumorigenicity

Inflammatory response
Ectopic tissue formation
Toxicity types, frequencies, and severity

Host immune response
Abnormal proliferation
Toxicity risk analysis: Potential clinical toxicities, projected risks, organ(s) affected, and indicators

Considerations for Toxicological Studies

With an experienced scientist, we have established the following general considerations for vaccine toxicological assessment:

Geno toxicology is generally not necessary, but required for new adjuvants;
Carcinogenicity is not needed;
Identifying (no adverse events level) NOAEL to provide evidence for the safety of vaccine;
Identifying any potential toxicities and target organs;
For immunogenicity, the endpoints need to be considered including antibody class, avidity, affinity, titer, half-life, function.
Additional endpoints include seroconversion rates, activation of cytokine secretion, other cell-mediated immune response, persistence of DNA plasmid in vaccine in tissues, stand-alone testing for novel adjuvants.

With the expertise of pre-clinical toxicological and specific animal models, Creative Biolabs can assist in performing the most appropriate toxicological studies to assess the safety data and help our clients to develop better vaccines. For more detailed information, please visit our website or contact us directly.