Abstract
Clinical trials of gene transfer have begun to validate the clinical potential of gene therapy. With this progress, attention has turned increasingly to analysing the ability of various methods of gene therapy to satisfy clinical and commercial needs. There are fundamental differences between cell-based therapies, which employ genetically modified cells as a therapeutic product, virus-based therapies, which employ recombinant viral vectors as a therapeutic product and gene-based therapies in which DNA itself is formulated as a pharmaceutical product, in terms of the technologies required to develop and produce the product, the mode of clinical application, the clinical risks and the economics of commercialisation. This report reviews the potential indications for gene therapy and the status of various approaches to gene therapy in development in the context of a field which is moving rapidly from basic research to product development.
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