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Mutation detection in plasmid‐based biopharmaceuticals
Author(s) -
Oliveira Pedro H.,
Prather Kristala L. J.,
Prazeres Duarte M. F.,
Monteiro Gabriel A.
Publication year - 2011
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201000372
Subject(s) - biopharmaceutical , plasmid , computational biology , nucleic acid , dna , biology , identification (biology) , biochemical engineering , microbiology and biotechnology , genetics , engineering , botany
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.