title: Mutation detection in plasmid-based biopharmaceuticals.
abstract: As the number of applications involving therapeutic plasmid DNA (pDNA) increases worldwide, there is a growing concern over maintaining rigorous quality control through a panel of high-quality assays. For this reason, efficient, cost-effective and sensitive technologies enabling the identification of genetic variants and unwanted side products are needed to successfully establish the identity and stability of a plasmid-based biopharmaceutical. This review highlights several bioinformatic tools for ab initio detection of potentially unstable DNA regions, as well as techniques used for mutation detection in nucleic acids, with particular emphasis on pDNA.
authors.affiliation: Institute for Biotechnology and Bioengineering, Center for Biological and Chemical Engineering, Instituto Superior Técnico, Lisbon, Portugal. pcoliveira@ist.utl.pt
authors.forename: Pedro H
authors.initials: PH
authors.lastname: Oliveira
authors.forename: Kristala L J
authors.initials: KL
authors.lastname: Prather
authors.forename: Duarte M F
authors.initials: DM
authors.lastname: Prazeres
authors.forename: Gabriel A
authors.initials: GA
authors.lastname: Monteiro
mesh_terms: D004247:DNA / Q000627:therapeutic use*; D042822:Genomic Instability / Q000235:genetics; D006801:Humans; D009154:Mutation; D010957:Plasmids / Q000627:therapeutic use*; D019444:Vaccines, DNA
chemical_list: D019444:Vaccines, DNA; D004247:DNA