Commercial production of transgenic crops genetically engineered to produce pharmaceuticals: Agriculture technology already exists to address most GMP issues

BioPharm International

Volumn 16, Issue 4, 2003, Pages 60-67

  Crosby, Lon ^a  

^a RC and D and Manages Numedloc Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGRICULTURE; DRUG COST; DRUG EXPOSURE; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG RESEARCH; ENVIRONMENTAL IMPACT; FOOD AND DRUG ADMINISTRATION; GENETIC ENGINEERING; GOOD MANUFACTURING PRACTICE; OCCUPATIONAL EXPOSURE; OCCUPATIONAL SAFETY; PRACTICE GUIDELINE; REVIEW; TRANSGENIC PLANT; TRANSGENICS;

EID: 0037393160     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. FDA, "Draft Good Guidance Practices (GGPs) in Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals," Federal Register 67(177), 57828-57829 (12 September 2002).
2. Mison, D. and Curling, J., "The Industrial Production Costs of Recombinant Therapeutic Proteins Expressed in Transgenic Corn," BioPharm 13(5), 48-54 (2000).
3. Baex, J. et al., "Corn Seed Production of Therapeutic Proteins Moves Forward," BioPharm 13(8), 50-54 (2000).
4. Center for Biologics Evaluation and Research, "Plant-Derived Biologics Meeting," Ames, IA, 5-6 April 2000.
5. Erwin, D.E., Transgenic Crops: An Environmental Assessment (Henry A. Wallace Center for Agricultural and Environmental Policy at Winrock International, Morrilton, AR, November 2000). Available at www.winrock.org/transgenic.pdf.
6. Pew Initiative on Food and Biotechnology, Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products (University of Richmond, Washington, DC, 2001).
7. Hansen, M.K. Genetic Engineering Is not an Extension of Conventional Plant Breeding: How Genetic Engineering Differs from Conventional Breeding, Hybridization, Wide-Crosses, and Horizontal Gene Transfer (Consumers Union, Yonkers, NY, January 2000).
8. Duffy, M., "Who Benefits from Biotechnology," paper presented at the American Seed Trade Association meeting, Chicago, IL 5-7 December 2001.
9. APHIS, A Summary of Confinement Measures for Organisms Being Field Tested in 2002 (USDA, Riverdale, MD, 21 May 2002). Available at www.aphis.usda.gov/ppq/biotech/pdf/pharm-2002.pdf.
10. Plant Biosafety Office, Plant Molecular Farming Discussion Document (Plant Health and Production Division, Ottawa, Canada).
11. "GMOs in 30% of 'Organic Soybeans," The Japan Times (29 August 2002).
12. Fay, T. and Phillips, N., "Safe Handling of Potent Compounds," Chem. Eng. 109(4), 62-68 (2002).
13. Copmann, T. et al., "One Product, One Process, One Set of Specifications: A Proven Quality Paradigm for the Safety and Efficacy of Biologic Drugs," BioPharm 14(3), 14-24 (2001).
14. Shippert, P., "Spotlight on Hyperspectral," Geospatial Solutions 12(2), 40-45 (2002).