Assessing Risks of Plant-Based Pharmaceuticals: I. Human Dietary Exposure

REFERENCES

• AgMRC (Agricultural Marketing Resource Center) . 2003 . The U.S. Corn Masa Industry: Structure and Implications for the Great Plains Region , Manhattan, Kansas, , USA : Department of Agricultural Economics, Kansas State University . Prepared for AgMARC by Sparks Companies, Inc.
   Google Scholar
• Azzoni , A R , Kusnaki , A R Miranda , E A . 2002 . Recombinant aprotinin produced in transgenic corn seed: Extraction and purification studies . Biotechnol Bioeng , 80 : 268 – 76 .
   PubMed Web of Science ®Google Scholar
• Basque , J-R and Ménard , D . 1999 . Establishment of culture systems of human gastric epithelium for the study of pepsinogen and gastric lipase synthesis and secretion . Microscopy Res Techn , 48 : 293 – 30 .
   Web of Science ®Google Scholar
• Bayer Pharmaceuticals Corporation . 2003 . Trasylol® Aprotinin Injection , West Haven, CT, , USA : Product Label .
   Google Scholar
• Beierlein , W , Scheule , A M Antoniadis , G . 2000 . An immediate, allergic skin reaction to aprotinin after reexposure to fibrin sealant . Transfusion , 40 : 302 – 05 .
   PubMed Web of Science ®Google Scholar
• Beyer , A J , Wang , K Umble , A N . 2007 . Low-dose exposure and immunogenicity of transgenic maize expressing the Escherichia coli heat-labile toxin B subunit . Environ Health Perspect , 115 : 354 – 60 .
   PubMed Web of Science ®Google Scholar
• Chikwamba , R , McMurray , J Shou , H . 2002 . Expression of a synthetic E. coli heat-labile enterotoxin B sub-unit (LT-B) in maize . Mol Breeding , 10 : 253 – 65 .
   Web of Science ®Google Scholar
• Chikwamba , R K , Scott , M P Mejia , L B . 2003 . Localization of a bacterial protein in starch granules of transgenic maize kernels . Proceed National Acad Sci , 100 : 11127 – 32 .
   PubMed Web of Science ®Google Scholar
• Christensen , P J , Misra , M K Rai , S . 2004 . Confined Production Processes for Non-food Corn. Biosafety Institute for Genetically Modified Agricultural Products , Ames, IA, , USA : Iowa State University .
   Google Scholar
• Coenen , T MM , Aughton , P and Verhagen , H . 1997 . Safety evaluation of lipase derived from Rhizopus oryzae: Summary of toxicological data . Food Chem Toxicol , 35 : 315 – 22 .
   PubMed Web of Science ®Google Scholar
• Fischer , R and Emans , N . 2000 . Molecular farming of pharmaceutical proteins . Transgenic Res , 9 : 279 – 9 .
   PubMed Web of Science ®Google Scholar
• Freese , B . 2005 . Biopharming: Case Study of Corn-Produced Aprotinin. Friends of the Earth, for Genetically Engineered Food Alert http://www.foe.org/biopharm/
   Google Scholar
• Giddings , G , Allison , G Brooks , D . 2000 . Transgenic plants as factories for biopharmaceuticals . Nature Biotechnol , 18 : 1151 – 55 .
   PubMed Web of Science ®Google Scholar
• Howard , J A and Donnelly , K C . 2004 . A quantitative safety assessment model for transgenic protein products produced in agricultural crops . J Agricul Environ Ethics , 17 : 545 – 5 .
   Web of Science ®Google Scholar
• ICH (International Conference on Harmonisation) . 1997 . Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, ICH Harmonised Tripartite Guideline S6, 16 July 1997 , Geneva, , Switzerland : ICH Secretariat .
   Google Scholar
• Kidwell , J L , Tomerline , J R and Petersen , B J . 2000 . DEEM® Dietary Exposure Evaluation Model , Washington, DC, , USA : Novigen Sciences, Inc. .
   Google Scholar
• Kirk , D D , McIntosh , K Walmsley , A M . 2005 . Risk analysis for plant-made vaccines . Transgenic Res , 14 : 449 – 62 .
   PubMed Web of Science ®Google Scholar
• Ma , JK-C , Drake , P MW and Christou , P . 2003 . The production of recombinant pharmaceutical proteins in plants . Nature Reviews Genetics , 4 : 794 – 80 .
   PubMed Web of Science ®Google Scholar
• Ma , JK-C , Barros , E Bock , R . 2005 . Molecular farming for new drugs and vaccines: Current perspectives on the production of pharmaceuticals in transgenic plants . EMBO Reports , 6 : 593 – 99 .
   PubMed Web of Science ®Google Scholar
• Meristem Therapeutics . 2006 . Merispase® Product Label Clermont-Ferrand, , France http://www.meristem-therapeutics.com/sommaire_en.php3
   Google Scholar
• Milano , C A , Patel , V S Smith , P K . 2002 . Risk of anaphylaxis from aprotinin re-exposure during LVAD removal and heart transplantation . J Heart Lung Transplant , 21 : 1127 – 30 .
   PubMed Web of Science ®Google Scholar
• Nap , J-D , Metz , P LJ Escaler , M . 2003 . The release of genetically modified crops into the environment: Part 1. Overview of current status and regulations . The Plant Journal , 33 : 1 – 18 .
   PubMed Web of Science ®Google Scholar
• Peterson , R KD and Arntzen , C J . 2004 . On risk and plant-based biopharmaceuticals . Trends in Biotechnol , 22 : 64 – 6 .
   PubMed Web of Science ®Google Scholar
• Pla , M , Messeguer , J and Mele , E . 2006 . Gene flow from GE to conventional maize using real-time PCR ISB News Report. August
   Google Scholar
• Prodigene . 2004 . AproliZean TM—Recombinant Aprotinin from Maize, Version I, 3/2004 www.prodigene.com
   Google Scholar
• Shama , L M . 2006 . Risk Assessment of Plant-Based Pharmaceuticals and Biologics , Masters Thesis Bozeman, MT, , USA : Montana State University .
   Google Scholar
• Shama , L M and Peterson , R KD . 2004 . The benefits and risks of producing pharmaceutical proteins in plants . Risk Management Matters , 2 : 28 – 3 .
   Google Scholar
• Tacket , C O , Mason , H S Losonsky , G . 1998 . Immunogenicity in humans of a recombinant bacterial antigen delivered in transgenic potato . Nature Med , 4 : 607 – 09 .
   PubMed Web of Science ®Google Scholar
• Trautschold , I , Werle , E and Zickgraf-kudel , G . 1967 . Trasylol . Biochem Pharmacol , 16 : 59 – 7 .
   Web of Science ®Google Scholar
• USDA APHIS (US Department of Agriculture Animal and Plant Health Inspection Service) . 2006 . Draft Guidance for APHIS Permits for Field Testing or Movement of Organisms with Pharmaceutical or Industrial Intent Washington, DC, , USA http://www.aphis.usda.gov/brs/pdf/Pharma_Guidance.pdf
   Google Scholar
• USEPA (U.S. Environmental Protection Agency) . 1997 . Exposure Factors Handbook Volume 1—General Factors Washington, DC, , USA EPA/600/P-95/002Fa
   Google Scholar
• Wang , K . 2006 . Personal communication , Ames, Iowa, , USA : Iowa State University .
   Google Scholar
• Wolt , J D , Wang , K and Peterson , R KD . 2006 . Assessing risk of unintended antigen occurrence in food: A case instance for maize-expressed LT-B . Hum Ecol Risk Assess , 12 : 856 – 7 .
   Web of Science ®Google Scholar
• Zhong , G Y , Peterson , D Delaney , D E . 1999 . Commercial production of aprotinin in transgenic maize seeds . Molecular Breeding , 5 : 345 – 56 .
   Web of Science ®Google Scholar