Specialty molecules from plants and in vitro cultures as new drugs: regulatory considerations from flask to patient
- 23 March 2022
- journal article
- research article
- Published by Springer Science and Business Media LLC in Plant Cell, Tissue and Organ Culture (PCTOC)
- Vol. 149 (1-2), 105-111
- https://doi.org/10.1007/s11240-022-02287-4
Abstract
Few therapeutic specialty molecules from in vitro cultures beyond paclitaxel have come to market and although other more complex products like ginseng have also appeared, success has been limited. Often it is not the science that is limiting, but rather regulatory issues that limit considerations of potential products mainly because of costs in getting the product to market. Here we discuss broader thinking of such specialty molecules in the form of dietary supplements, nutraceuticals, herbal medicines, botanical drugs, and pure molecules along with potential complex products from a regulatory standpoint and especially within the realm of approved botanical drugs, e.g., Veregen and Fulyzaq, that have new drug applications (NDAs). The United States food and drug administration (US FDA) regulatory categories are used to provide examples of alternative product options that could prove useful for taking specialty molecules to market.Keywords
This publication has 23 references indexed in Scilit:
- Synthetic biology’s first malaria drug meets market resistanceNature, 2016
- Botanicals as “new” drugs: US developmentEpilepsy & Behavior, 2015
- Vinca Alkaloids2013
- Artemisinin production in Artemisia annua: studies in planta and results of a novel delivery method for treating malaria and other neglected diseasesPhytochemistry Reviews, 2010
- Large Scale Culture of Ginseng Adventitious Roots for Production of GinsenosidesPublished by Springer Science and Business Media LLC ,2009
- New therapies from old medicinesNature Biotechnology, 2008
- Production of the antimalarial drug precursor artemisinic acid in engineered yeastNature, 2006
- Engineering a mevalonate pathway in Escherichia coli for production of terpenoidsNature Biotechnology, 2003
- Camptothecin and taxol: from discovery to clinicJournal of Ethnopharmacology, 1996
- Cell Culture of Taxus as a Source of the Antineoplastic Drug Taxol and Related TaxanesNature Biotechnology, 1992