NDLI: Plasmid DNA vaccine vector design: impact on efficacy, safety and upstream production.

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Plasmid DNA vaccine vector design: impact on efficacy, safety and upstream production.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Williams, James A. Carnes, Aaron E. Hodgson, Clague P.
Description	Country affiliation: United States Author Affiliation: Williams JA ( Nature Technology Corporation, Lincoln, NE 68521, USA. jim@natx.com)
Abstract	Critical molecular and cellular biological factors impacting design of licensable DNA vaccine vectors that combine high yield and integrity during bacterial production with increased expression in mammalian cells are reviewed. Food and Drug Administration (FDA), World Health Organization (WHO) and European Medical Agencies (EMEA) regulatory guidance's are discussed, as they relate to vector design and plasmid fermentation. While all new vectors will require extensive preclinical testing to validate safety and performance prior to clinical use, regulatory testing burden for follow-on products can be reduced by combining carefully designed synthetic genes with existing validated vector backbones. A flowchart for creation of new synthetic genes, combining rationale design with bioinformatics, is presented. The biology of plasmid replication is reviewed, and process engineering strategies that reduce metabolic burden discussed. Utilizing recently developed low metabolic burden seed stock and fermentation strategies, optimized vectors can now be manufactured in high yields exceeding 2 g/L, with specific plasmid yields of 5% total dry cell weight.
File Format	HTM / HTML
ISSN	07349750
e-ISSN	18731899
DOI	10.1016/j.biotechadv.2009.02.003
Journal	Biotechnology Advances
Issue Number	4
Volume Number	27
Language	English
Publisher	Elsevier
Publisher Date	2009-07-01
Publisher Place	Great Britain (UK)
Access Restriction	Open
Subject Keyword	Discipline Biotechnology Genetic Therapy Genetic Vectors Plasmids Vaccines, Dna Animals Escherichia Coli Genetics Metabolism Fermentation Gene Expression Mammals Immunology
Content Type	Text
Resource Type	Article
Subject	Bioengineering Applied Microbiology and Biotechnology Biotechnology

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