Throughout the 1980s and early 1990s, the term 'biopharmaceutical' had become virtually synonymous with 'proteins of therapeutic use' (Chapter 1). Nucleic-acid-based biopharmaceuticals, too, harbour great potential. Current developments in nucleic-acid-based therapeutics centre around gene therapy, as well as antisense technology (including RNAi) and aptamer technology, all of which are discussed later in this chapter. These technologies have the potential to revolutionize medical practice. Despite all the hype, however, it is important to note that by early 2007 at least, only three nucleic-acid-based products had gained approval worldwide: one antisense-based product (tradename Vitravene), one aptamer (tradename Macugen) and one gene therapy product (tradename Gendicine, approved only in China). In contrast, some 165 protein-based biopharmaceuticals had been approved by early 2007. The full benefit of nucleic-acid-based medicines will accrue only after the satisfactory resolution of several technical difficulties currently impeding their routine medical application.

Cell-based medicines also harbour tremendous potential. Although a small number of such products have gained approval, none is a stem-cell-derived product. Cell-based biopharmaceuti-cals are discussed towards the end of this chapter.

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