title: On risk and plant-based biopharmaceuticals.
abstract: Research into plant-based expression of pharmaceutical proteins is proceeding at a blistering pace. Indeed, plants expressing pharmaceutical proteins are currently being grown in field environments throughout the USA. But how are these plants and proteins being assessed for environmental risk and how are they being regulated? Here, we examine the applicability of the risk assessment paradigm for assessing human and ecological risks from field-grown transgenic plants that express pharmaceutical proteins.
authors.affiliation: Agricultural and Biological Risk Assessment, Department of Entomology, Montana State University, Bozeman, MT 59717-3020, USA. bpeterson@montana.edu
authors.forename: Robert K D
authors.initials: RK
authors.lastname: Peterson
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Arntzen
mesh_terms: D001702:Biopharmaceutics / Q000331:legislation & jurisprudence / Q000379:methods*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000378:metabolism*; D015202:Protein Engineering / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D011640:Public Policy; D011994:Recombinant Proteins / Q000096:biosynthesis* / Q000235:genetics / Q000627:therapeutic use*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013673:Technology Assessment, Biomedical / Q000379:methods*
chemical_list: D011994:Recombinant Proteins