Potential for transgenic animals in the biopharmaceutical industry

Transgenic animals may have advantages over existing biopharmaceutical production methods with respect to the quantity and quality of the source material, which may subsequently reduce production costs and simplify downstream processing. In addition, the attractions of transgenic animals as a means of production include the ability to produce adequate quantities of materials required at a scale of production which may otherwise be prohibitively expensive because of the significant amounts needed for therapy. Indeed, high level expression of complex molecules in an appropriately modified form has already been achieved for a number of clinically relevant proteins. Notwithstanding these successes, the lack of livestock embryonic stem cells means that the generation of transgenic animals is currently relatively expensive and imprecise. Indeed, the isolation and characterization of these cells for livestock species would represent a significant step forward for the technology. Finally, in terms of production of novel or improved human therapeutic products by the biopharmaceutical industry, a choice must now be made between mammalian cell culture, with its proven track record of producing safe and effective products, and transgenic animal technology. Transgenic animal technology may be superior in production yields and costs, but in Australia at least, has yet to clear regulatory hurdles and has disadvantages in terms of time required for product development.