Chapter 30 : Biosafety in the Pharmaceutical Industry

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this chapter:
Zoom in

Biosafety in the Pharmaceutical Industry, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555815899/9781555813390_Chap30-1.gif /docserver/preview/fulltext/10.1128/9781555815899/9781555813390_Chap30-2.gif


This chapter addresses the biosafety challenges commonly experienced in cultivating recombinant and pathogenic microbes and the use of mammalian cells for the production of therapeutic proteins and viruses. It summarizes the place and application of viruses, bacteria, and fungi in pharmaceutical research and development. Recombinant viral agents have become a significant starting material for both gene therapy and vaccine production. Recombinant bacteria are frequently used to produce pharmacological proteins, enzymes, and plasmid DNA. The two bacterial species most frequently employed are and . Containment for fungi and yeasts can vary from biosafety level 1 (BSL-1) for organisms such as through BSL-3 for species. Containment for known fungi should follow the recommendations provided by national guidelines, such as in (BMBL). Mammalian cells may be used for the direct generation of pharmacological proteins, usually created by recombinant DNA techniques. The biosafety regulations utilized at a specific company are frequently dictated by the home country for the organization. Clinical assays can present challenge for the biosafety professional within the pharmaceutical industry. The global harmonization of biosafety practices would allow benchmarking to determine the best practices for this industry.

Citation: Meechan P, Gyuris J, Petuch B, Chartrain M, Herber W. 2006. Biosafety in the Pharmaceutical Industry, p 551-560. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch30

Key Concept Ranking

Equine infectious anemia virus
Highlighted Text: Show | Hide
Loading full text...

Full text loading...


Image of FIGURE 1

Simplified flowchart for containment of newly isolated organisms.

Citation: Meechan P, Gyuris J, Petuch B, Chartrain M, Herber W. 2006. Biosafety in the Pharmaceutical Industry, p 551-560. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch30
Permissions and Reprints Request Permissions
Download as Powerpoint


1. Barta,, J., A. Blum,, D. Inloes,, J. Lindsay,, A. Nash,, M. Bosenge,, L. Staub, and, J. Walcroft. 1998. Environmental control and monitoring in bulk manufacturing facilities for biological products. Pharm. Technol. 22:4046.
2. Bent,, R. 1997. Protein expression, p. 16.0.1–16.0.3. In F. M. Ausubel,, R. Brent,, R. E. Kingston,, D. D. Winkelman,, J. G. Seidman,, J. A. Smith, and, K. Struhl (ed.), Current Protocols in Molecular Biology, vol. 3. John Wiley & Sons, Inc., New York, N.Y.
3. Berlex. 2002. Leukine sargramostim prescribing circular. Bosenge, Montville, N.J. [Online.] http://www.berlex.com/html/products/pi/Leukine_PI.pdf.
4. Campbell, W. C. 1989. Ivermectin and Abamectin. Springer-Verlag, New York, N.Y.
5. Centers for Disease Control and Prevention. 2004. 42 CFR 73. Select Agent Regulations. U.S. Code of federal Regulations.
6. Centers for Disease Control and Prevention and National Institutes of Health. 1999. Biosafety in Microbiological and Biomedical Laboratories, 4th ed. U.S. Government Printing Office, Washington, D.C.
7. Condreay,, J. P.,, S. M. Witherspoon,, W. C. Clay, and, T. A. Kost. 1999. Transient and stable gene expression in mammalian cells transduced with a recombinant baculo-virus vector. Proc. Natl. Acad. Sci. USA 96:127132.
8. Food and Drug Administration. 1999. Evolving scientific and regulatory perspectives on cell substrates for vaccine development. Workshop report. U.S. Food and Drug Administration, Rockville, Md.
9. Food and Drug Administration. 2004. 21 CFR Part 211. Current Good Manufacturing Practices for finished pharmaceuticals. U.S. Code of Federal Regulations.
10. Freshney, R. I. 2002. Culture of Animal Cells, 4th ed. A Manual of Basic Technique. Wiley-Liss Inc., New York, N.Y.
11. GlaxoSmithKline. 2004. Engerix-B prescribing circular. Bosenge, Research Triangle Park, N.C. [Online.] http://gskvaccines.com/vaccines/pages/vaccines_prescribing.jsp?product=ENGERIXB_ADULT.
12. Handelsman, J., et al. 1998. Molecular biological access to the chemistry of unknown soil microbes: a new frontier for natural products. Chem. Biol. 5:R245R249.
13. Health Canada. 1999. Asperillus spp. In Material Safety Data SheetInfectious Substances. [Online.] http://www.phac-aspc.gc.ca/msds-ftss/msds11e.html.
14. Hunter-Cevera, J., and, A. Belt. 1999. Isolation of cultures, p. 3–20. In A. L. Demain and J. E. Davies (ed.), Manual of Industrial Microbiology and Biotechnology, 2nd ed. ASM Press, Washington, D.C.
15. Knight, V., et al. 2003. Diversifying microbial natural products for drug discovery. Appl. Microbiol. Biotechnol. 62:446458.
16. Kost, T. A., and, J. P. Condreay. 2002. Recombinant baculoviruses as mammalian cell gene-delivery vectors. Trends Biotechnol. 20:173180.
17. Kuhnert,, P., J. Hacker,, I. Muhldorher,, A. P. Burnens,, J. Nicolet, and, J. Frey. 1997. Detection system for Escherichia coli-specific virulence genes: absence of virulence determinants in B and C strains. Appl. Environ. Microbiol. 63:703709.
18. Liberman, D. L. 1993. Biowaste management in bioprocessing, p. 769–787. In G. Stephanopolos (ed.), Biotechnology, 2nd ed., vol. 3. VCH Verlagsgesellschaft mbH, Weinheim, Germany.
19. Liberman, D. L.,, R. Fink, and, F. Schaefer. 1999. Biosafety and biotechnology, p. 300–308. In A. L. Demain and J. E. Davies (ed.), Manual of Industrial Microbiology and Biotechnology, 2nd ed. ASM Press, Washington, D.C.
20. Merck & Co. Inc. 2004a. Recombivax HB prescribing circular. Merck & Co. Inc., Whitehouse Station, N.J. [Online.] http://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf.
21. Merck & Co. Inc. 2004b. Zocor (simvistatin) prescribing circular. Merck & Co. Inc., Whitehouse Station, N.J. [Online.] http://merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf.
22. National Institutes of Health. 2002. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 59 FR 34496 (July 5, 1994), as amended. [Online; the current version can be accessed at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.]
23. Novartis Pharmaceuticals Corp. 2004. Sandimmune prescribing circular. Novartis Pharmaceuticals Corp., East Hanover, N.J. [Online.] http://www.novartis-transplant.com/medpro/prescribe_info.jsp.
24. Occupational Safety and Health Administration. 2004. 29 CFR 1910.1030. Bloodborne Pathogen Standard. U.S. Code of Federal Regulations.
25. Ortho-McNeil Pharmaceuticals, Inc. 1999. Regranex product insert. Ortho-McNeil Pharmaceuticals, Inc., Raritan, N.J. [Online.] http://regranex.com/content/backgrounders/www.regranex.com/www.regranex.com/PI_Full_Version.pdf.
26. Sinclair, A., and, M. H. J. Ashley. 1995. Sterilization and containment, p. 553–558. In J. A. Asenjo and J. C. Merchuk (ed.), Bioreactor System Design. Marcel Dekker, Inc., New York, N.Y.
27. Strobel, G., and, D. Bryn. 2003. Bioprospecting for microbial endophytes and their natural products. Microbiol. Mol. Biol. Rev. 67:491502.
28. Vesley, D. 1986. Decontamination, sterilization, disinfection, and antisepsis in the microbiology laboratory, p. 182–198. In B. M. Miller (ed.), Laboratory Safety: Principles and Practices. American Society for Microbiology, Washington, D.C.
29. Wave Biotech LLC. 2003. Sterile Tubing Fuser-IR: operation and validation guide. Wave Biotech LLC, Bridgewater, N.J.
30. World Health Organization. 1992. Expert Committee on Specifications for Pharmaceutical Preparations, Thirty- Second Report. World Health Organization, New York, N.Y.
31. Zhu,, J., M. Grace,, J. Casale,, A. T. Chang,, M. L. Musco,, R. Bosenge,, R. Greenberg,, E. Schaefer, and, S. R. Indelicatio. 1999. Characterization of replication-competent adenovirus isolates from large-scale production of a recombinant adenoviral vector. Hum. Gene Ther. 10:113121.

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error