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

Drake, PMW; Szeto, TH; Paul, MJ; Teh, AY-H; Ma, JK-C (2016) Recombinant biologic products versus nutraceuticals from plants - a regulatory choice? British Journal of Clinical Pharmacology, 83 (1). pp. 82-87. ISSN 1365-2125 https://doi.org/10.1111/bcp.13041
SGUL Authors: Drake, Pascal Teh, Yi Hui

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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.

Item Type: Article
Additional Information: This is the peer reviewed version of the following article: Drake, P. M. W., Szeto, T. H., Paul, M. J., Teh, A. Y.-H., and Ma, J. K.-C. (2016) Recombinant biologic products versus nutraceuticals from plants – a regulatory choice?. Br J Clin Pharmacol, 83: 82–87., which has been published in final form at http://dx.doi.org/10.1111/bcp.13041 . This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving
Keywords: GMP, manufacturing, monoclonal antibody, recombinant pharmaceutical, transgenic plants, Pharmacology & Pharmacy, 1115 Pharmacology And Pharmaceutical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: British Journal of Clinical Pharmacology
ISSN: 1365-2125
Language: ENG
Dates:
DateEvent
13 June 2016Published Online
10 June 2016Accepted
9 December 2016Published
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
AdG 269110European Research Councilhttp://dx.doi.org/10.13039/501100000781
PubMed ID: 27297459
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/108192
Publisher's version: https://doi.org/10.1111/bcp.13041

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