Production of Plasmid DNA as Pharmaceutical

Part of the Methods in Molecular Biology book series (MIMB, volume 1317)


Pharmaceutical applications of plasmid DNA require certain quality standards, depending on the intended use of the plasmids. That is, for direct gene transfer into human, GMP Grade is mandatory, however, for GMP production of for example viral vectors (AAV or mRNA etc.), the plasmid DNA used has not to be produced under GMP necessarily.

Here we summarize important features of producing plasmid DNA, ensuring the required quality for the intended (pharmaceutical) application.

Key words

Plasmid DNA Gene therapy Vaccination Vector production Fermentation Plasmid topology CGE analysis Quality assurance Quality control Pharmaceutical scale GMP grade High quality grade 


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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.PlasmidFactory GmbH & Co. KGBielefeldGermany

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