Abstract
Within the last five years, the exponential growth of research activities on the development of genetic vaccination and gene therapy has made it necessary to develop an easy, cost-effective, industrial scale process for production of plasmid DNA (see Note 1). One main issue is that the process should conform to cGMP guidelines and be acceptable to the FDA or other national regulatory agencies. The cGMP environment should be implemented independently of the intended use of the DNA product.
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© 2000 Humana Press Inc., Totowa, NJ
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Schorr, J., Moritz, P., Schleef, M. (2000). Production of Plasmid DNA in Industrial Quantities According to cGMP Guidelines. In: Lowrie, D.B., Whalen, R.G. (eds) DNA Vaccines. Methods in Molecular Medicine™, vol 29. Humana Press. https://doi.org/10.1385/1-59259-688-6:11
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DOI: https://doi.org/10.1385/1-59259-688-6:11
Publisher Name: Humana Press
Print ISBN: 978-0-89603-580-5
Online ISBN: 978-1-59259-688-1
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