Article | June 24, 2011

Trends In The Manufacturing Of Viral Gene Therapeutics And Next Generation Vaccines

Source: SAFC

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Article: Trends In The Manufacturing Of Viral Gene Therapeutics And Next Generation Vaccines

By Jeff Strobel, Site Director, SAFC Carlsbad, CA

Much of the technology used for the current manufacturing of viral vaccines has its roots in discoveries from the gene therapy industry. Gene therapy, or more correctly, gene transfer, is a catch-all phrase for those products which use a viral vector, plasmid, or cell as a delivery vehicle for a gene product. Early applications in this field really developed in the 1980s and 1990s, often using viral vectors such as adenovirus or retrovirus to deliver genes. There are still no approved gene therapy products in the western world, but numerous applications are being pursued, notably in cancer, central nervous system disorders and cardiac disease. There are also some exciting studies for diseases of the eye. In sum, researchers are now being more realistic than in the early days, seeing the future of gene therapy in providing effective treatments, not cures.

In the early days of gene therapy, the safety of viral vectors was a real issue, and two incidents in particular caused a great deal of concern. The first, a teenager being treated for ornithine transcarbamylase deficiency at the University of Pennsylvania, died four days after being treated with an adenovirus loaded with a corrected gene after a massive immune response to the virus. In the second incident, a group of French children with severe combined immunodeficiency, or ‘bubble boy' disease, were cured but developed leukemia after the retrovirus vector integrated itself preferentially into certain sites. While still an experimental therapy, the dangers are now much better understood, and the issues facing companies with gene therapy products have a more defined standard of efficacy and safety.

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Article: Trends In The Manufacturing Of Viral Gene Therapeutics And Next Generation Vaccines