Mutation detection in plasmid-based biopharmaceuticals

Authors

  • Dr. Pedro H. Oliveira,

    Corresponding author
    1. Institute for Biotechnology and Bioengineering, Center for Biological and Chemical Engineering, Instituto Superior Técnico, Lisbon, Portugal
    • IBB, Center for Biological and Chemical Engineering, Instituto Superior Técnico, Av. Rovisco Pais 1049-001 Lisbon, Portugal, Fax: +351-218419062
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  • Kristala L. J. Prather,

    1. Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA
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  • Duarte M. F. Prazeres,

    1. Institute for Biotechnology and Bioengineering, Center for Biological and Chemical Engineering, Instituto Superior Técnico, Lisbon, Portugal
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  • Gabriel A. Monteiro

    1. Institute for Biotechnology and Bioengineering, Center for Biological and Chemical Engineering, Instituto Superior Técnico, Lisbon, Portugal
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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.

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