Manufacturing and quality control of cell-based tumor vaccines: a scientific and a regulatory perspective.

Tumor vaccines play an increasingly important role in the therapy of various malignant diseases. The efficacy of these new products is currently being explored in many clinical trials all over the world. Cell-based tumor vaccines can be classified as somatic cell therapy, or, depending on whether genetic modifications have been applied, as gene-transfer medicinal products. Few specific guidance documents are available to standardize the development and production of cell-based tumor vaccines. Here, we review the different types of cell-based cancer vaccines that are currently being used in clinical trials. Furthermore, we discuss regulatory guidance documents available in the European Union and describe methods that have been applied so far to ensure that the cell-based vaccines meet acceptable standards, including potency assays.