Recombinant biologic products versus nutraceuticals from plants – a regulatory choice?. (28th July 2016)

• Record Type: Journal Article
• Authors: Drake, Pascal M. W.; Szeto, Tim H.; Paul, Mathew J.; Teh, Audrey Y.‐H.; Ma, Julian K‐C.
• Is Part Of: British journal of clinical pharmacology. Volume 83:Number 1(2017:Jan.)
• Page Start: 82
• Page End: 87
• Publication Date: 2016-07-28
• Subjects: GMP -- manufacturing -- monoclonal antibody -- recombinant pharmaceutical -- transgenic plants; Pharmacology -- Periodicals; Drugs -- Periodicals; 615.1
• DOI: 10.1111/bcp.13041
• Languages: English
• ISSNs: 0306-5251

Abstract

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.