Scientific Publications by FDA Staff

Dev Biol 2004;116:53-9

Regulatory expectations during product development for tumour vaccines.

Kawakami K, Puri RK

Among various approaches for the treatment of cancer, tumour vaccines stimulate the host immune response against cancer and produce local inflammation that may result in the regression of existing tumour in the body. Therapeutic tumour vaccines may generally be grouped into cellular vaccines, synthetic peptides, purified or recombinant proteins, and multi-antigen preparations including shed, or secreted antigens or cell lysates. While no tumour vaccines have been licensed by the U.S. Food and Drug Administration (FDA), a large number of products and approaches are being developed and numerous clinical trials are currently ongoing. In this article, we summarize regulatory issues associated with different types of tumour vaccines. The step-wise approach to regulatory requirements including current good manufacturing practices (cGMPs) and characterization of these vaccines at various stages of product development is discussed.