title: Plasmid DNA manufacturing technology.
abstract: Today, plasmid DNA is becoming increasingly important as the next generation of biotechnology products (gene medicines and DNA vaccines) make their way into clinical trials, and eventually into the pharmaceutical marketplace. This review summarizes recent patents and patent applications relating to plasmid manufacturing, in the context of a comprehensive description of the plasmid manufacturing intellectual property landscape. Strategies for plasmid manufacturers to develop or in-license key plasmid manufacturing technologies are described with the endpoint of efficiently producing kg quantities of plasmid DNA of a quality that meets anticipated European and FDA quality specifications for commercial plasmid products.
authors.affiliation: Nature Technology Corporation, Lincoln, NE 68521, USA. acarnes@natx.com
authors.forename: Aaron E
authors.initials: AE
authors.lastname: Carnes
authors.forename: James A
authors.initials: JA
authors.lastname: Williams
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000379:methods*; D004247:DNA / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification*; D005060:Europe; D008004:Licensure / Q000331:legislation & jurisprudence / Q000639:trends; D010330:Patents as Topic; D010957:Plasmids / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification*; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification
chemical_list: D019444:Vaccines, DNA; D004247:DNA