Recombinant biologic products versus nutraceuticals from plants – a regulatory choice?

Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regul...

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Bibliographic Details
Published in:British journal of clinical pharmacology 2017-01, Vol.83 (1), p.82-87
Main Authors: Drake, Pascal M. W., Szeto, Tim H., Paul, Mathew J., Teh, Audrey Y.‐H., Ma, Julian K‐C.
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal
Biological Products - standards
Biotechnology - legislation & jurisprudence
Biotechnology - methods
Dietary Supplements - standards
Drug Labeling
Erice Review‐themed Issue
GMP
Legislation, Drug
manufacturing
Molecular Farming - legislation & jurisprudence
Molecular Farming - methods
monoclonal antibody
Plants, Genetically Modified
recombinant pharmaceutical
Recombinant Proteins - biosynthesis
Recombinant Proteins - standards
Review‐themed Issue
transgenic plants
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Summary:Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regulatory path for such new pharmaceuticals has been a deterrent. Consideration has been given to using alternative regulatory paths, including those for nutraceuticals or cosmetic agents. This review will consider these possibilities, and discuss the difficulties in establishing regulatory guidelines for new pharmaceutical manufacturing technologies.
ISSN:0306-5251
1365-2125
DOI:10.1111/bcp.13041