Recombinant biologic products versus nutraceuticals from plants - a regulatory choice?
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.
Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Pascal M W
PM
Drake
Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Tim H
TH
Szeto
Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Mathew J
MJ
Paul
Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Audrey Y-H
AY
Teh
Institute for Infection and Immunity, St. George's Hospital Medical School, London, SW17 0RE, UK.
Julian K-C
JK
Ma
D000911:Antibodies, Monoclonal; D001688:Biological Products / Q000592:standards; D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000379:methods*; D019587:Dietary Supplements / Q000592:standards; D004348:Drug Labeling; D007880:Legislation, Drug; D058634:Molecular Farming / Q000331:legislation & jurisprudence / Q000379:methods*; D030821:Plants, Genetically Modified; D011994:Recombinant Proteins / Q000096:biosynthesis* / Q000592:standards
D000911:Antibodies, Monoclonal; D001688:Biological Products; D011994:Recombinant Proteins
GMP; manufacturing; monoclonal antibody; recombinant pharmaceutical; transgenic plants