title: Perspectives on plasmid-based gene therapy: challenges for the product and the process.
abstract: Clinical trials for gene-therapy products began in the 1990s. Currently, most of the 630 completed or on-going trials are in Phase I and II. Because of the safety issues surrounding the use of viral vectors, approx. 25% of the ongoing clinical trials use DNA plasmids to carry the corrective gene (http://www.wiley.co.uk/genmed). The purpose of this perspective (and this issue) is to highlight some of the unique technical challenges and potential solutions associated with the manufacture and expression of a plasmid-based gene-therapy product.
authors.affiliation: Chemical Engineering Department, Villanova University, 318 White Hall, 800 Lancaster Ave, Villanova, PA 19085, USA. william.j.kelly@villanova.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Kelly
mesh_terms: D016503:Drug Delivery Systems / Q000295:instrumentation / Q000379:methods*; D015195:Drug Design; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods*; D005818:Genetic Engineering / Q000379:methods*; D015316:Genetic Therapy / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis* / Q000302:isolation & purification; D010957:Plasmids / Q000096:biosynthesis* / Q000138:chemical synthesis* / Q000302:isolation & purification / Q000627:therapeutic use
chemical_list: D004364:Pharmaceutical Preparations