Scaling-up recombinant plasmid DNA for clinical trial: current concern, solution and status.

Ruzila Ismail, Zeenathul Nazariah Allaudin, Mohd-Azmi Mohd Lila

Laboratory of Immunotherapeutic and Vaccines, Institute of Bioscience, Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia.

Vaccine 2012 Sep 7

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Gene therapy and vaccines are rapidly developing field in which recombinant nucleic acids are introduced in mammalian cells for enhancement, restoration, initiation or silencing biochemical function. Beside simplicity in manipulation and rapid manufacture process, plasmid DNA-based vaccines have inherent features that make them promising vaccine candidates in a variety of diseases. This present review focuses on the safety concern of the genetic elements of plasmid such as propagation and expression units as well as their host genome for the production of recombinant plasmid DNA</a>. The highlighted issues will be beneficial in characterizing and manufacturing plasmid DNA for save clinical use. Manipulation of regulatory units of plasmid will have impact towards addressing the safety concerns raised in human vaccine applications. The gene revolution with plasmid DNA by alteration of their plasmid and production host genetics will be promising for safe delivery and obtaining efficient outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Citation

Ruzila Ismail, Zeenathul Nazariah Allaudin, Mohd-Azmi Mohd Lila. Scaling-up recombinant plasmid DNA for clinical trial: current concern, solution and status. Vaccine. 2012 Sep 7;30(41):5914-20