Journal
MOLECULAR BIOTECHNOLOGY
Volume 17, Issue 2, Pages 143-149Publisher
HUMANA PRESS INC
DOI: 10.1385/MB:17:2:143
Keywords
DNA vaccines; regulatory process; quality; preclinical safety
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Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination map not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes as the development of a novel vaccine could be problematic owing to the starting material often being developed in a research laboratory under ill-defined conditions. This paper examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the potential for the formation of anti-DNA antibodies.
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