11
Views
6
CrossRef citations to date
0
Altmetric
Research Article

Scientific and Regulatory Aspects of Macromolecular Drugs and Devices

, , &
Pages 873-968 | Published online: 20 Oct 2008

REFERENCES

  • Edrnond, S. K., Grady, L. T., Outschoorn, A. S., Rhodes, C. T., (1986). Monoclonal Antibodies as Drugs and Devices, Drug Develop. Ind. Pharm., 12 (1 and 2), 107–228.
  • Elander, R. P., (1985). Biotechnology: Present and Future Roles in the Pharmaceutical Industry, Drug Develop. Ind. Pharm., 11:5, 965–999.
  • “Hormone Drugs,” Proceedings of FDA-USP Workshop, May 1982, United States Pharmacopeia Convention, Inc., Maryland, (1982).
  • “Impacts of Applied Genetics, Microorganisms, Plants and Animals,” United States Congress, Office of Technology Assessment, Washington, D. C. (1981).
  • “Insulins, Growth Hormone and Recombinant DNA Technology,” ed., John L. Gueriguian, Raven, New York, (1981).
  • “Monoclonal Hybridoma Antibodies: Techniques and Applications,” ed., John G. R. Hurrell, CRC, Florida, (1982).
  • “Recombinant DNA Products: Insulin, Interferon and Growth Hormone,” ed., Arthur P. Bollon, CRC, Florida, (1984).
  • Watson, J. D., Tooze, J., Kurtz, D. T., “Recombinant DNA, a Short Course,” Scientific American, New York, (1983).
  • Berman, P. W., Lasky, L. A., (1985). Engineering Glycoproteins for use as Pharmaceuticals, Trends Biotech., 3:2, 51–53.
  • Blundell, T., Sternberg, M. J. E., (1985). Computer-aided Design in Protein Engineering, Trends Biotech., 3:9.
  • Burke, D. C, (1985). The Interferons, Br. Med. Bulletin, 41:4, 333–338.
  • Depinho, R. A., Feldman, L. B., Scharff, M. D., (1986). Tailor-Made Monoclonal Antibodies, Ann. Intern. Med., 104, 225–233.
  • Harris, W. J., Strategies for Selection of Appropriate Biotechnologies for Industrial Applications, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 9–25.
  • Hinman, A. R., Bart, K. J., Orenstein, W. A., (1985). New Vaccines, Int. J. Epid., 14: 4, 502–503.
  • Hitzeman, R. A., Leung, D. W., Perry, L. J., Kohr, W. J., Levine, H. L., Goeddel, D. V., (1983). Secretion of Human Interferons by Yeast, Science, 219, 620–625.
  • Inada, Y., Yoshimoto, T., Matsushima, A., Saito, Y., (1986). Engineering Physicochemical and Biological Properties of Proteins by Chemical Modification, Trends Biotech., 4:3, 68–73.
  • Johnson, I. S., (1983). Human Insulin from Recombinant DMA Technology, Science, 219, 632–637.
  • Keus, J. A. R., (1986). An Accidental Human Trial of Recombinant Vaccina Virus: A Step Towards Acceptance of Live Recombinant Vaccines?, Trends Biotech., 4:5.
  • Khachatourians, G. G., Haffie, T. L., Biotechnology: Applications to Genetics, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 243–249.
  • Klausner, A., (1986). Researchers Probe Second-Generation t-PA, Bio/Tech., 4, 706–711.
  • Nowinski, R. C, Tarn, M. R., Goldstein, L. C, Stong, L., Kuo, C, Corey, L., Stamm, W. E., Handsfield, H. H., Knapp, J. S., Holmes, K. K., (1983). Monoclonal Antibodies for Diagnosis of Infectious Diseases in Humans, Science, 219, 637–644.
  • Sadee, W., (1986). Protein Drugs: A Revolution in Therapy?, Pharm. Res., 3:1, 3–6.
  • Scott, M. G., (1985). Monoclonal Antibodies-Approaching Adolescence in Diagnostic Immunoassays, Trends Biotech., 3:7, 170–174.
  • Ulmer, K. M., (1983). Protein Engineering, Science, 219, 666–670.
  • Van Brunt, J., (1986). Neuropeptides: The Brain's Special Messengers, Bio/tech., 4.
  • Van Brunt, J., (1986). Protein Architecture: Designing from the Ground Up, Bio/tech., 4, 277–283.
  • Vournakis, J. N., Elander, R. P., (1983). Genetic Manipulation of Antibiotic-Producing Microorganisms, Science, 219, 703–708.
  • Yelverton, E., Norton, S., Obijeski, J. E., Goeddel, D. V. (1983). Rabies Virus Glycoprotein Analogs: Biosynthesis in Escherichia coU, Science, 219, 614–619.
  • Arathoon, W. R., Birch, J. R., (1986). Large-Scale Cell Culture in Biotechnology, Science, 232, 1390–1395.
  • Bebbington, C, Hentschel, C, (1985). The Expression of Recombinant DMA Products in Mammalian Cells, Trends Biotech., 3:12.
  • Birch, J. R., Boraston, R., Wood, L., (1985). Bulk Production of Monoclonal Antibodies in Fermenters, Trends Biotech., 3:7, 162–166.
  • Bok, S. H., (1985). Improving the Production of Recombinant DNA Proteins Through Fermentation Development, Pharm. Manufac, Jan., 40–42.
  • Borrebaeck, C. A. K., (1986). In vitro Immunisation for Production of Murine and Human Monoclonal Antibodies: Present Status, Trends Biotech., 4:6, 147–152.
  • Browne, M. J., Dodd, I., Carey, J. E., Chapman, C. G., Robinson, J. H., (1985). Increased Yield of Human Tissue-Type Plasminogen Activator Obtained by Means of Recombinant DNA Technology, Thromb. Hemost., 54:2, 422–424.
  • Burnett, K. G., Martinis, J., Bartholomew, R. M., Production of Bifunctional Antibodies by Hybridoma Technology, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 401–409.
  • Caulcott, C. A., Rhodes, M., (1986). Temperature-Induced Synthesis of Recombinant Proteins, Trends Biotech., 4:6, 142–146.
  • Chisti, Y., Moo-Young, M., (1986). Disruption of Microbial Cells for Intracellular Products, Enzyme Microb. Technol., 8:4, 194–204.
  • Cooney, C. L., (1983). Bioreactors: Design and Operation, Science, 219, 728–733.
  • Crawford, M. A., Johnson, R. W., (1985). Contamination Control in a Class 100 Tissue Culture Media Production Facility, Pharm. Manufac, Jan., 33–37.
  • Duff, R. G., (1985). Microencapsulation Technology: A Novel Method for Monoclonal Antibody Production, Trends Biotech., 3:7.
  • Feder, J., Tolbert, W. R., (1983). The Large-Scale Cultivation of Mammalian Cells, Scientific American, 248:1, 36–43.
  • Fleischaker, R. J., (1986). Applying Large-Scale Culture Techniques to the in vitro Production of Monoclonal Antibodies, Pharm. Manufac, Jan., 16–21.
  • Giorgio, R. J., Wu, J. J., (1986). Design of Large Scale Containment Facilities for Recombinant DNA Fermentations, Trends Biotech., 4:3, 60–65.
  • Hartmeier, W., (1985). Immobilized Biocatalysts-From Simple to Complex Systems, Trends Biotech., 3:6, 149–152.
  • Jarvis, A. P., Grdina, T. A., (1983). Production of Biologicals from Microencapsulated Living Cells, Biotechniques, March-April, 22–27.
  • Jay, E., Rommens, J., Jay, G., Synthesis of Mammalian Proteins in Bacteria, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 388–399.
  • Karubie, I., Biosensors in Fermentation and Environmental Control, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 135–155.
  • Kronenberg, L. H., Interferons: Manufacture and Application in Medicine, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 451–461.
  • Mizrahi, A., (1986). Biologicals from Animal Cells in culture, Bio/tech., 4, 123–127.
  • Muth, W. L., Large-Scale Fermentation development of Recombinant Microorganisms, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 156–164.
  • Posillico, E. G., (1986). Microencapsulation Technology for Large-Scale Antibody Production, Bio/tech., 4, 114–117.
  • Ratafia, M., (1986). Current Issues in the Scale-Up of Biotechnology Processes, Pharm. Tech., June, 42–52.
  • Reuveny, S., Zheng, Z. B., Eppstein, L., (1986). Evaluation of a Cell Culture Fermenter, Am. Biotech. Lab., Jan/Feb, 28–39.
  • Van Brunt, J., (1985). Scale-Up: The Next Hurdle, Bio/tech., 3:5, 419–424.
  • Van Brunt, J., (1986). Fermentation Economics, Bio/tech., 4:5, 395–401.
  • Van Brunt, J., (1986). Immobilized Mammalian Cells: The Gentle Way to Productivity, Bio/tech., 4:6, 505–510.
  • Weetall, H. H., Pitcher, W. H., (1986). Scaling Up an Immobilized Enzyme System, Science, 232, 1396–1403.
  • Albert, W. H. W., Krueger, D., (1986). Quality Assurance of Therapeutics Based on Monoclonal Antibodies, An European Viewpoint. Boehringer Mannheim GmbH, Biochemical Research Center, D-8132, Tutzing, Germany, F. R.
  • Alving, B. M., Finlavm, J. S., (1979). Immunoglobulins: Characteristics and Use of Intravenous Preparations, FDA, Bureau of Biologies.
  • Bethell, D. R., Dawson, M., Lafoe, M. J., (1985). Characterization of Monoclonal Antibodies to Cell Surface Antigens by Particle Concentration Fluorescence Immunoassay (PCFIA), Biotechniques, 3:6, 466–473.
  • Birch, J. R., Hill, C. R., Kenney, A. C, Affinity Chromatography: Its Role in Industry, in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette, (1985), 594–605.
  • Collen, D., Rijken, D. C, Van Damme, J., Billiau, A., (1982). Purification of Human Tissue-Type Plasminogen Activator in Centigram Quantities from Human Melanoma Cell Culture Fluid and its Conditioning for Use in-vivo, Thromb., Hemost., 48:3, 294–296.
  • Fung, H-L., Chapter seven in “Modern Pharmaceutics,” eds., Gilbert S. Banker and Christopher T. Rhodes, Marcel Dekker Inc., (1979).
  • Gooding, R. P., Bristow, A. F., (1985). Detection of Host-Derived Contaminants in Products of Recombinant DNA Technology in E. coli: A Comparison of Silver Staining and Immunoblotting, J. Pharm. Pharmacol., 37, 781–786.
  • Grau, U., (1985). Fingerprint Analysis of Insulin and Proinsulins, Diabetes, 34, 1174–1180.
  • Gubler, U., Chua, A. O., Stern, A. S., Hellmann, C. P., Vitek, M. P., Dechiara, T. M., Benjamin, W. R., Collier, K. J., Dukovich, M., Familletti, P. C, Fiedler-Nagy, C, Jenson, J., Kaffka, K., Kilian, P. L., Stremlo, D., Wittreich, B. H., Woehle, D. Mizel, S. B., Lomedico, P. T., (1986). Recombinant Human Interleukin 1: Purification and Biological Characterization, J. Immunol., 136:7, 2492–2497.
  • Hayakawa, T., Kawamura, J., (1983). The Product Quality Assurance Criteria for the Medically Important Polypeptides Produced by Recombinant DNA Technology, Iyakuhin Kenkyu, 14:2, 171–191.
  • Hou, K. C, Mandaro, R. M., (1986). Bioseparation by Ion Exchange Cartridge Chromatography, BioTechniques, 4:4, 358–367.
  • Hunkapiller, M. W., Hood, L. E., (1983). Protein Sequence Analysis: Automated Microsequencing, Science, 219, 650–659.
  • Hustedt, M., Kroner, K. H., Menge, U., Kula, M-R., (1985) Protein Recovery Using Two-Phase Systems, Trends Biotech., 3:6, 139.
  • Kadam, K. L., (1986). Reverse Micelles as a Bioseparation Tool, Enzyme Microb. Technol., 8, 266–273.
  • Kirkwood, T. B. L., (1977). Predicting the Stability of Biological Standards and Products, Biometrics, 33, 736–742.
  • Kurokawa, M., (1979). J. Biological Standardization, 7, 31–41.
  • “Monoclonal Antibodies: Standardization of their Characterization and Use.” Developments in Biological Standardization. Vol. 57 (1985), ed., The International Association of Biological Standardization.
  • Patel, P. R., Enzyme Isolation and Purification in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette (1985), 534–562.
  • Porterfield, R. I., (1984). Application of kinetic models and Arrhenius methods to product stability evaluation, Pharm. Technol., 45–50.
  • Proceedings of the 26th Annual Conference of Pharmaceutical Analysis, July 1986, Merrimac, Wisconsin: sponsored by The School of Pharmacy, University of Wisconsin-Madison.
  • Rhodes, C. T., (1984). An overview of kinetics for the evaluation of pharmaceutical systems, Drug Develop. Ind. Pharm., 8 and 9, 1163–1174.
  • Rhodes, W. E., (1985). Monoclonal Antibodies for in-vivo Use: In-Process and Final Testing, Pharm. Manufac, April, 12–14.
  • Rhodes, W. E., (1985). Routine Release Testing for in-vivo Monoclonal Antibodies, Pharm. Manufac, May, 12–14.
  • Rijken, D. C, Collen, D., (1981). Purification and Characterization of the Plasminogen Activator Secreted by Human Melanoma Cells in Culture, J. Biol. Chem., 256: 13, 7035–7041.
  • Roseto, A., Guillemin, M-C, Chehimi, J., Mazeron, M. C., Peries, J., (1984). Elimination of Mycoplasma, Bacteria, and Fungi Contaminants of Hybridoma Cultures by Intraperitoneal Passage in the Mouse, Hybridoma, 3:3, 297–299.
  • Sofer, G. K., (1986). Current Applications of Chromatography in Biotechnology, Bio/tech., 4, 712–715.
  • Standardization and Control of Biologicals Produced by Recombinant DNA Technology.” Developments in Biological Standardization Vol. 59 (1985), ed., The International Association of Biological Standardization.
  • Sulkowski, E., (1985). Purification of Proteins by IMAC, Trends Biotech., 3:1, 1–6.
  • Tydeman, M. S., Kirkwood, T. B. L., (1984). Design and analysis of accelerated degradation tests for the stability of biological standards, J. Biological Standardization, 12, 195–206.
  • Wolfe, A. J., Worthington, H. F. C, (1976). Use of the Arrhenius equation, Drug Develop. Ind. Pharm., 1, 185–194.
  • Wong, B. L., Charm, S. E., (1983). Product Recovery from Genetically Engineered Organisms: A Review of the Practical Problems, Genet. Eng. News, March/April.
  • Benson, R. H., (1986). Biotechnology Patent Pit Falls, Bio/tech., 4.
  • Bliem, R., (1986). ESACT '85 Meeting Report, Products from transformed Cell Lines: The Stance of WHO and FDA, Trends Biotech., 4:1, 1–2.
  • Gartland, W. J., Government Guidelines in “Biotechnology Applications and Research,” Technomic, eds., Cheremisinoff and Ouellette (1985), 29–40.
  • Gibbs, J. N., (1986). Regulating Bioengineered Veterinary Drugs Bio/tech., 4, 414–416.
  • Halperin, J. A., (1985). Helping Drug Regulatory Authorities tc Help You, Clin. Res. Practices and Drug Reg. Affairs, 3:2, 167–184.
  • Korwek, E. L., (1982). FDA, OSHA, and EPA Regulation of the Recombinant DNA Technology, J. Parenteral Sci. Technol., 36:6, 251–255.
  • Linhardt, R. J., (1986). Protein Engineering and Site-Directed Mutagenesis, Patents, Applied Biochem. Biotech. 13, 75–79.
  • Miller, H. I., (1982). Recombinant DNA as a Paradigm of New Technology: Its Impact on Regulation by the Food and Drug Administration, J. Parenteral Sci. Technol., 36:6, 248–250.
  • Rhodes, W. E., (1985). Monoclonal Antibodies as Drugs: A Manufacturing and Regulatory Overview, Pharm. Manufac, Jan
  • Petricciani, J. C., (1985). Regulatory Considerations for Products Derived from the New Biotechnology, Pharm. Manufac, March, 31–34.
  • Federal Register, Vol. 51, No. 123, Thursday, June 26, 1986. Part II, Office of Science and technology Policy, “Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment. “
  • Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. (1985). Office of Biologies Research and Review, Center for Drugs and Biologies, Food and Drug Administration (FDA), Bethesda, MD 20205.
  • Points to Consider in the Manufacture of Monoclonal Antibody Products for Human Use (1983). Office of Biologies, FDA.
  • Points to Consider in the Manufacture of in-vitro Monoclonal Antibody Products Subject to Licensure. (1983). Office of Biologies, FDA.
  • Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans (1983). Office of Biologies, FDA.
  • Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1984). Office of Biologies, FDA.
  • Guideline on General Principles of Process Validation (1984). Division of Drug Quality Compliance, Office of Drugs, FDA.
  • Blumenthal, D., Gluck, M., Louis, K. S., Stoto, M. A., Wise, D., (1986). University-Industry Research Relationships in Biotechnology: Implications for the University, Science, 232, 1361–1366.
  • Dibner, M. D., (1986). Biotechnology in Europe, Science, 232, 1367–1372.
  • Dibner, M. D., (1985). The Biotech Connection, Pharm. Exec. Sept., 81–84.
  • Elander, R. P., (1985). Biotechnology: Present and Future Roles in the Pharmaceutical Industry, Drug Develop. Ind. Pharm., 11:5, 965–999.
  • Evans, S., Grassam, P., (1986). Considerations for Parenteral Dosage Form Development of Natural Alpha Interferon, J. Parenteral Sci. Technol., 40:3, 83–87.
  • Harford, S., (1983). Recombinant DNA Technology and The Pharmaceutical Industry, The Pharm. J., London, Sept. 17, 320.
  • Klausner, A., (1985). Words of Caution as Monoclonals Mature, Bio/tech., 4, 604.
  • Murray, J. R., (1986). The First $4 Billion is the Hardest, Bio/tech., 4, 293–296.
  • Norris, C. E., (1986). Tax and the Business of Biotechnology, Trends Biotech., 4:7, 169–172.
  • Prescott, L., (1983). Hybritech: Portrait of a Monoclonal Specialist, Bio/tech., April, 156–161.
  • Van Brunt, J., (1986). Contract Production: Buying Technical Expertise, Bio/tech., 4, 701–705.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.