Literature DB >> 27297459

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

Pascal M W Drake1, Tim H Szeto1, Mathew J Paul1, Audrey Y-H Teh1, Julian K-C Ma1.   

Abstract

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.
© 2016 The British Pharmacological Society.

Keywords:  GMP; manufacturing; monoclonal antibody; recombinant pharmaceutical; transgenic plants

Mesh：

Substances：

Year:  2016        PMID： 27297459      PMCID： PMC5338133          DOI： 10.1111/bcp.13041

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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5.  Production of Recombinant Proteins in Transgenic Tobacco Plants.

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8.  Gas Exchange Rates Decrease and Leaf Temperature Increases in Nicotiana benthamiana Leaves Transiently Overexpressing Hemagglutinin in an Agrobacterium-Assisted Viral Vector System.

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