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

Paper ID Volume ID Publish Year Pages File Format Full-Text
14499 1225 2009 18 PDF Available
Title
Plasmid DNA vaccine vector design: Impact on efficacy, safety and upstream production
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.

Keywords
DNA vaccine; Plasmid; Vector; Fermentation; Escherichia coli; Gene therapy
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Plasmid DNA vaccine vector design: Impact on efficacy, safety and upstream production
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Publisher
Database: Elsevier - ScienceDirect
Journal: Biotechnology Advances - Volume 27, Issue 4, July–August 2009, Pages 353–370
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us