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KMID : 1142220080030010079
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Regulatory Research on Food, Drug & Cosmetic
2008 Volume.3 No. 1 p.79 ~ p.86
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Safety and quality evaluation of DNA vaccines
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Cho Hee-Jeong
Kim Young-Boong
Oh Yu-Kyung
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Abstract
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With development of molecular biology techniques, DNA vaccines encoding the antigen have been drawing attention as a new generation vaccine. Since approximately 40 DNA vaccines are already in clinical trials worldwide, specific guidelines on DNA vaccines have been notified by regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and Korea Food and Drug Administration (KFDA). Safety evaluation of DNA vaccine includes the genotoxicity study testing the integration of plasmid DNA into host genome, and immunotoxicity study testing the induction of autoimmune diseases. For quality assurance of DNA vaccines, the control of the starting materials and manufacturing process (in-process control) is very important. Similar to other biological products, endotoxin, stability and sterility tests are generally required for the quality control of DNA vaccines. With the progresses on the DNA vaccine development, the guidelines for assuring the quality and safety evaluation of DNA vaccine may become more elaborated and sophisticated to tailor the unique properties of nucleic acid-based vaccines.
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KEYWORD
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DNA vaccine, regulation, safety, quality evaluation
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