The regulation of biologic products derived from bioengineered plants.
Recently, there has been a large increase in the number and types of biological products--from therapeutic antibodies to vaccines for the prevention of infectious diseases--that are produced in bioengineered plant systems. We anticipate that this technology will be used increasingly on a commercial scale for the manufacture of human and animal products. These production systems have the capacity to produce very large quantities of products at lower costs and with reduced risks compared with mammalian systems.
Stein
K E
KE
Division of Monoclonal Antibodies, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, 29 Lincoln Drive, 20892-4555, Bethesda, MD, USA. stein@cber.fda.gov
Webber
K O
KO
D000818:Animals; D001688:Biological Products / Q000592:standards*; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards*; D004274:DNA, Recombinant; D005818:Genetic Engineering; D006023:Glycoproteins / Q000737:chemistry; D006801:Humans; D007878:Legislation as Topic; D030821:Plants, Genetically Modified; D012639:Seeds / Q000235:genetics; D014481:United States; D016885:United States Department of Agriculture; D014486:United States Food and Drug Administration
D001688:Biological Products; D004274:DNA, Recombinant; D006023:Glycoproteins