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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Published inBritish journal of clinical pharmacology Vol. 83; no. 1; pp. 82 - 87
Main Authors Drake, Pascal M. W., Szeto, Tim H., Paul, Mathew J., Teh, Audrey Y.‐H., Ma, Julian K‐C.
Format Journal Article
LanguageEnglish
Published England John Wiley and Sons Inc 01.01.2017
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
manufacturing
transgenic plants
GMP
monoclonal antibody
recombinant pharmaceutical
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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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
content type line 23
ObjectType-Review-1
Equal contribution; joint first authors.
ISSN:0306-5251
1365-2125
DOI:10.1111/bcp.13041