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

Autor: Drake PM; Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK., Szeto TH; Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK., Paul MJ; Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK., Teh AY; Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK., Ma JK; Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Jazyk: angličtina
Zdroj: British journal of clinical pharmacology [Br J Clin Pharmacol] 2017 Jan; Vol. 83 (1), pp. 82-87. Date of Electronic Publication: 2016 Jul 28.
DOI: 10.1111/bcp.13041
Abstrakt: 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.)
Databáze: MEDLINE
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