2012, Number 2
<< Back Next >>
Residente 2012; 7 (2)
Eventos históricos, políticos y científicos de la biotecnología aplicada a la investigación biofarmacéutica en humanos
Tera PS, Cuaxospa JJA
Language: Spanish
References: 25
Page: 70-75
PDF size: 310.00 Kb.
ABSTRACT
The use of microorganisms for the purpose of human use is not something recent; since ancient times civilizations have incorporated biological products and microorganisms to production processes. However, in order for these strategies to be described and developed with scientific bases, and transferred to a medical and pharmacological context, the structural nature of DNA and proteins had to be elucidated. Drugs of biotechnological origin have become strongly positioned within the market, partly due to the fact that time and money invested in developing them are considerably less than for a conventional drug. Economists foresee that in the decades to come, at least 50% of new drugs will be monoclonal antibodies. The effort to standardize exchangeability with biocomparable drugs has started in Mexico, and will position the country as a pioneer worldwide.
REFERENCES
Bull AT, Holt G, Lilly MD. Biotechnology: International trends and perspectives. Paris: OECD; 1982.
Berman A. Romantic Hygeia: JJ Viery (1775-1846). Bulletin of the History of Medicine 1965; (39): 134-142.
Dornbusch H. Egyptian beer for the living, the dead and the gods. BeerAdvocate Exclusive, 2005.
Piskur J et al. How did Saccharomyces evolve to become a good brewer? Trends Genet 2006; 22(4): 183-6.
Bud R. History of biotechnology. In: The uses of life: a history of biotechnology. New York: Cambridge University Press; 1994: 524-531.
Löffler A. Trends in biotechnology: implications for the pharmaceutical industry. Journal of Medical Marketing: Device. Diagnostic and Pharmaceutical Marketing, 2002; 2(4): 345-348.
Rajewsky K. Obituary: Cesar Milstein (1927-2002). Nature 2002; 416(6883): 806-806.
Melchers F. Georges Kohler (1946-95). Nature 1995; 374(6522): 498-498.
Cohen SN et al. Construction of biologically functional bacterial plasmids in vitro. Proc Natl Acad Sci USA 1973; 70(11): 3240-3244.
Bera RK. The story of the Cohen-Boyer patents. Current Science 2009; 96(6): 760-763.
Alkan SS. Monoclonal antibodies: the story of a discovery that revolutionized science and medicine. Nat Rev Immunol 2004; 4(2): 153-156.
Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256(5517): 495-497.
Galambos L, Sturchio JL, Pharmaceutical firms and the transition to biotechnology: a study in strategic innovation. The Business History Review 1998; 72(2): 250-278.
Barfoed H. Insulin production technology. Chemical Engineering Progress 1987; 83(10): 49-54.
Ladisch MR, Kohlmann KL. Recombinant human insulin. Biotechnology Progress 1992; 8(6): 469-478.
Federación, D.O.d.l., Grupo de Autoridades Regulatorias y Expertos. Facultad de Medicina, UNAM, 2011-2012.
Tollman P et al. A revolution in R&D: How genomics and genetics are transforming the biopharmaceutical industry, 2001, The Boston consulting group: Boston.
Arlington S et al. Pharma 2010: The threshold to innovation. Somers, NY: IBM Business Consulting Services, 2002.
Meibohm B, Derendorf H. Pharmacokinetics and Pharmacodynamics of biotech drugs. In: Kayser O, Müller RH editors. Pharmaceutical biotechnology. 2004, Wiley-VHC: Weinheim.
DeLamarter J, Fumero S. Today’s alliances for tomorrow’s medicines. Drug Discov World 3, 2002;. Fall: 9-14.
Krull IS, Swartz M. Validation in biotechnology and well-Characterized biopharmaceutical products. Pharmaceutical Regulatory Guidance Book 2006.
Carr CD, LCGC, LC Column Technology Supplement. 2006: 44.
ICH-Q5B, Quality of biotechnological products: Analysis of the expression construct in cell lines used for production of r-DNA derived protein products. European Medicines Agency, 1996. CPMP/ICH/139/95.
ICH-Q5D, Quality of biotechnological products: derivation and characterization of cell substrates used for production of biotechnological/biological products. European Medicines Agency, 1998. CPMP/ICH/294/95.
ICH-Q5A, Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. European Medicines Agency, 1997. CMP/ICH/195/95.