title: Production of Plasmid DNA as Pharmaceutical.
abstract: 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.
authors.affiliation: PlasmidFactory GmbH & Co. KG, Meisenstrasse 96, 33739, Bielefeld, Germany.
authors.forename: Marco
authors.initials: M
authors.lastname: Schmeer
authors.forename: Martin
authors.initials: M
authors.lastname: Schleef
mesh_terms: D004247:DNA / Q000378:metabolism*; D006801:Humans; D008967:Molecular Biology / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D010957:Plasmids / Q000378:metabolism*; D011786:Quality Control; D012926:Social Control, Formal
chemical_list: D004364:Pharmaceutical Preparations; D004247:DNA