B) Danzas de corte
4. LA DANZA DESDE EL PUNTO DE VISTA MORAL
4.1. LOS DEBATES SOBRE LA LICITUD DEL TEATRO Y LA DANZA
The last decade has seen a drastic transformation of the bulk drug manufacturing milieu, including the adoption by the research-based drug industry of a business model (perhaps approached as a gospel in some cases) that greatly reduces the role of bulk drug manufacturing in-house and increas-ingly places it with outside suppliers. The latter have prolifer-ated in the rush to capture a more profitable business that fine and specialty chemicals, and many are fully engaged in drug intermediates and bulk drug manufacturing, to the point that by 2002–2004 overcapacity exists.
Inevitably, this has had a major impact on the bulk drug process development as well. Given the manufacturing driver for this shift, the overall outsourcing topic will be discussed in the next chapter, including the said impact on the bulk process development.
VIII. IN CLOSING
Clearly, this chapter has described bulk drug process develop-ment as a complex, richly textured activity that is deeply
rooted in scientific and engineering skill. The discussion has been largely based in the context of a large drug company where all the requisite skills reside, mostly in R&D, but com-plemented well by those of the downstream organizations.
The reader may well ask, particularly as the new drug business faces increased pressures to do it faster and in a more regulated environment, does the smaller organization have a chance to succeed? What if the seemingly indispensable critical mass is not there and, instead, the task must be done by dovetailing as best one can resources and functions from multiple organizations? To the author the answer is clear.
Bulk drug process development is a business where size mat-ters and matmat-ters greatly, and if success is measured by the timely introduction of new drugs (not just one drug at a time) on a broad marketing base, then the smaller organizations labor at a disadvantage and the virtual company struggles with projects of any scope. Indeed, for bulk drug projects of unusual technical difficulty, the smaller organization seems faced with insuperable odds. Yet, none of this denies the opportunity for the bulk drug process developer practitioner to excel and find professional fulfillment in any environment without regard to size; all that is needed is the requisite skill and dedication to one’s work, as well as reaching out for the best possible collaborations that might be available.
REFERENCES
1. Pisano GP, Wheelwright SC. The new logic of high-tech.
Harvard Bus Rev 1995; 73:93–105.
2. Gadamasetti KG. Process chemistry in the pharmaceutical industry: an overview. In: Gadamasetti KG, ed. Process Chem-istry in the Pharmaceutical Industry. New York: Marcel Dekker, 1999:3–17.
3. Repicˇ O. Principles of Process Research and Chemical Develop-ment in the Pharmaceutical Industry. New York: John Wiley &
Sons, 1998.
4. Anderson NG. Practical Process Research and Development.
San Diego, CA: Academic Press, 2000.
5. Lee S, Robinson G. Process Development—Fine Chemicals from Grams to Kilograms. Oxford, UK: Oxford University Press, 1995.
6. Atherton JH, Carpenter KJ. Process Development—Physico-chemical Concepts. Oxford, UK: Oxford University Press, 1999.
7. Laird T, ed. Organic Process Research & Development. ISSN 1083–6160. Columbus, OH: American Chemical Society, 1997.
8. Flickinger MC, Drew SW. Encyclopedia of Bioprocess Technol-ogy. New York: John Wiley & Sons, 1999.
9. Calam CT. Process Development in Antibiotic Fermentations.
Cambridge, UK: Cambridge University Press, 1987.
10. Atkinson B, Matuvina F. Biochemical Engineering and Biotech-nology Handbook. 2nd ed. New York: Stockton Press, 1991.
11. Saunders J. Top Drugs—Top Synthetic Routes. Oxford, UK:
Oxford University Press, 2000.
12. Corey EJ, Cheng X-M. The Logic of Chemical Synthesis. New York: John Wiley and Sons, 1998.
13. Shinkai I, et al. Tetrahedron Lett 1982; 23:4903–4910.
14. Lin JH, Ostovic D, Vacca JP. The story of CrixivanÕ, an HIV protease inhibitor. In: Borchardt RT, et al, eds. In: Integration of Pharmaceutical Discovery and Development—Case His-tories. New York: Plenum Press, 1998:233–255.
15. Trost BM. The atom economy: a search for synthetic efficiency.
Science 1991; 254:1471–1473.
16. Soderberg AC. Fermentation design. In: Vogel HC, ed.
Fermentation and Biochemical Engineering Handbook. Park Ridge, NJ: Noyes Publications, 1983.
17. Verrall M, ed. Downstream Processing of Natural Products. A Practical Handbook. New York: Wiley, 1996.
18. Mathieu M. New Drug Development: A Regulatory View. 5th ed. Waltham, MA: Parexel, 2000.
19. Berry IR, Harpaz D. Validation of Bulk Pharmaceutical Chemicals. Buffalo Grove, IL: Interpharm Press, 1997.
20. Paul EL. Design of reaction systems for specialty organic chemicals. Chem Eng Sci 1998; 43:1773–1782.
21. Proctor LD, Wart AJ. Development of a continuous process for the industrial generation of diazomethane. Org Process R&D 2002; 6:884–892.
22. Martinelli MJ, Varie DL. Design and development of practical synthesis of LY228729. In: Gadamasetti KG, ed. Process Chemistry in the Pharmaceutical Industry. New York: Marcel Dekker, 1999:153–172.
23. McConville FX. The Real Pilot Plant Book. Worcester, MA:
McConville, 2002.
24. Crowl DA, Louvar JF. Chemical Process Safety. Fundamentals with Applications. Englewood Cliffs, NJ: PTR Prentice-Hall, 1990:17–19.
25. Ramondetta M, Repossi A, eds. Seveso, 20 Years After. Milano, Italy: Fondazione Lombardia per l’Ambiente, 1998.
26. Stull DR. Fundamentals of fire and explosion. Am Inst Chem Eng (AIChE) Monograph Ser 1977; 73:10.
27. Center for Chemical Process Safety. Guidelines for Reactivity Evaluation and Application to Process Design. New York:
AIChE, 1995:9–173.
28. Barton J, Rogers R. Chemical Reaction Hazards—a Guide to Safety. 2nd ed. Rugby, UK: Institution of Chemical Engineers, 1997:1–84.
29. Rowe SM. Thermal stability: a review of methods and interpre-tation of data. Org Process R&D 2002; 6:877–883.
30. Skelton B. Process Safety Analysis. An Introduction. Houston, TX: Gulf Publishing Company, 1997.
31. Allen DT, Shonnard DA. Green Engineering—Environmen-tally Conscious Design of Chemical Processes. Upper Saddle River, NJ: Prentice-Hall, 2002.
32. Venkataramani E, et al. Design of an expert system for early environmental assessment of manufacturing processes. Pro-ceedings of the 43rd Purdue Industrial Waste Conference.
Boca Raton, FL: Lewis Publishers, 1989.