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Chapter 31 : Biosafety in the Pharmaceutical Industry

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Biosafety in the Pharmaceutical Industry, Page 1 of 2

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Abstract:

Pharmaceutical companies that employ pathogenic microorganisms to produce vaccines and sometimes pharmaceuticals must establish a broad range of biosafety practices to ensure the safety of their employees as well as their products. At the drug discovery stage, especially during the search for candidates from natural sources, these safety practices must allow the research laboratories to cultivate myriad microorganisms, many of which are initially unknown. During scale-up, the biosafety practices employed should be in harmony with international guidelines to ensure that the manufacturing process and product may be implemented and sold, respectively, in other countries. Because the biosafety concerns experienced in pharmaceutical research laboratories are quite similar to those discussed in earlier chapters, they will not be repeated here. Therefore, this chapter briefly addresses the biosafety challenges commonly experienced in cultivating recombinant and pathogenic microbes. The use of mammalian cells for the production of therapeutic proteins and viruses will also be addressed.

Citation: Petuch B. 2017. Biosafety in the Pharmaceutical Industry, p 585-595. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch31
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Figures

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Figure 1

Simple fermenter sampling device.

Citation: Petuch B. 2017. Biosafety in the Pharmaceutical Industry, p 585-595. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch31
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Image of Figure 2
Figure 2

Steam sterilizable sampling device.

Citation: Petuch B. 2017. Biosafety in the Pharmaceutical Industry, p 585-595. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch31
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References

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1. Strauss BE, Costanzi-Strauss E. 2007. Combating oncogene activation associated with retrovirus-mediated gene therapy of X-linked severe combined immunodeficiency. Braz J Med Biol Res 40:601613.[PubMed]
2. Zhu J, Grace M, Casale J, Bordens R, Greenberg R, Schaefer E, Chang AT-I, Musco ML, Indelicato SR. 1999. Characterization of replication-competent adenovirus isolates from large-scale production of a recombinant adenoviral vector. Hum Gene Ther 10:113121.[PubMed]
3. Condreay JP, Witherspoon SM, Clay WC, Kost TA. 1999. Transient and stable gene expression in mammalian cells transduced with a recombinant baculovirus vector. Proc Natl Acad Sci USA 96:127132.[PubMed]
4. National Institutes of Health. 2013. Guidelines for research involving recombinant DNA molecules (NIH Guidelines). http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf, accessed 3/29/2016.
5. Campbell WC (ed). 1989. Ivermectin and Abamectin. Springer-Verlag, New York.
6. Bent R,. 1997. Protein expression, p 16.0.1–16.0.3. In Ausubel FM, Brent R, Kingston RE, Moore DD, Seidman JG, Smith JA, Struhl K (ed). Current Protocols in Molecular Biology, vol. 3. John Wiley & Sons, Inc., New York, NY.
7. Kuhnert P, Hacker J, Mühldorfer I, Burnens AP, Nicolet J, Frey J. 1997. Detection system for Escherichia coli-specific virulence genes: absence of virulence determinants in B and C strains. Appl Environ Microbiol 63:703709.[PubMed]
8. Merck. 2014. Recombivax HB® prescribing circular. Merck & Co. Inc., Whitehouse Station, NJ. https://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf, accessed 3/29/2016.
9. GlaxoSmithKline. 2015. Engerix-B® prescribing circular. GlaxoSmithKline Research Triangle Park, NC. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Engerix-B/pdf/ENGERIX-B.PDF, accessed 3/29/2015
10. Sanofi-Aventis. 2015. Leukine® prescribing circular. sanofi-aventis U.S. LLC Bridgewater, NJ. http://products.sanofi.us/Leukine/Leukine.html, accessed 3/29/2016.
11. Smith & Nephew. 2014. Regranex® product insert. Smith & Nephew, Inc. Fort Worth, Tx. http://www.regranex.com/pdf/PI_Full_Version.pdf, accessed 3/29/2016.
12. Cregg JM, Tolstorukov I, Kusari A, Sunga J, Madden K, Chappell T. 2009. Expression in the yeast Pichia pastoris. Methods Enzymol 463:169189.[PubMed]
13. Kobayashi K. 2006. Summary of recombinant human serum albumin development. Biologicals 34:5559.[PubMed]
14. Hamilton SR, Davidson RC, Sethuraman N, Nett JH, Jiang Y, Rios S, Bobrowicz P, Stadheim TA, Li H, Choi BK, Hopkins D, Wischnewski H, Roser J, Mitchell T, Strawbridge RR, Hoopes J, Wildt S, Gerngross TU. 2006. Humanization of yeast to produce complex terminally sialylated glycoproteins. Science 313:14411443.
15. Merck. 2015. Zocor® prescribing circular. Merck & Co. Inc., Whitehouse Station, NJ. https://www.merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf, accessed 3/29/2016.
16. Parke-Davis. 2015. Lipitor® prescribing circular. Parke-Davis, Division of Pfizer, NY, NY. http://labeling.pfizer.com/ShowLabeling.aspx?id=587, accessed 3/29/2016.
17. Novartis. 1998. Sandimmune® prescribing circular. Novartis Pharmaceuticals Corp., East Hanover, NJ. https://www.pharma.us.novartis.com/product/pi/pdf/sandimmune.pdf, accessed 3/29/2016.
18. Freshney RI. 2016. Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications, 10th ed. John Wiley and Sons, New York, NY.
19. Food and Drug Administration. 1999. Evolving scientific and regulatory perspectives on cell substrates for vaccine development. US Food and Drug Administration Workshop Report, Rockville, MD.
20. GlaxoSmithKlein. 2015. Cervarix® Highlights of Prescribing Information GSK, Research Triangle Park, NC. http://us.gsk.com/products/assets/us_cervarix.pdf, accessed 3/29/2016.
21. Ferrer-Miralles N, Domingo-Espín J, Corchero JL, Vázquez E, Villaverde A. 2009. Microbial factories for recombinant pharmaceuticals. Microb Cell Fact 8:1725.[PubMed]
22. Allergan. 2015. BOTOX® prescribing information. Allergan, Inc., Irvine, CA. https://www.botoxchronicmigraine.com/?cid=sem_goo_43700007526995097, accessed 3/29/2016.
23. Merck. 2015. ENCEVAC® TC-4 with HAVLOGEN® technical information. Merck Animal Health, Madison, NJ. http://www.merck-animal-health-usa.com/products/130_120671/productdetails_130_121133.aspx, accessed 3/29/2016.
24. US Federal Select Agent Program. 2014. Inspection checklists. http://www.selectagents.gov/resources/Checklist-NIH-BL2-LS.pdf, http://www.selectagents.gov/resources/Checklist-NIH-BL3-LS.pdf, accessed 3/29/2016.
25. Food and Drug Administration. 2015. 21CFR Part 211. Current Good Manufacturing Practices for finished pharmaceuticals. US Code of Federal Regulations. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211, accessed 3/29/2015.
26. Naumann BD, Sargent EV, Starkman BS, Fraser WJ, Becker GT, Kirk GD. 1996. Performance-based exposure control limits for pharmaceutical active ingredients. Am Ind Hyg Assoc J 57: 3342.[PubMed]
27. Centers for Disease Control and Prevention. 2009. Biosafety in Microbiological and Biomedical Laboratories. Government Printing Office, Washington, DC.
28. World Health Organization. 2014. Expert Committee on Specifications for Pharmaceutical Preparations, 49th Report. WHO, New York, NY.
29. Occupational Safety and Health Administration. 1999. (29 CFR 1910.1030). Bloodborne Pathogen Standard. US Code of Federal Regulations.
30. Liberman DL,. 1993. Biowaste management in bioprocessing, pp. 769787. In Stephanopolos G (ed). Biotechnology, 2nd ed., vol. 3. VCH Verlagsgesellschaft mbH, Wienheim, Germany.
31. Lieberman DL, Fink R, Schaefer F,. 1999. Biosafety and biotechnology, p 300308. In Demain AL, Davies JE (ed). Manual of Industrial Microbiology and Biotechnology, 2nd ed. American Society for Microbiology, Washington, D.C.
32. Barta J, Blum A, Inloes D, Lindsay J, Nash A, Olson M, Staub L, Walcroft J. 1998. Environmental control and monitoring in bulk manufacturing facilities for biological products. Pharm Technol 22:4046.
33. Sinclair A, Ashley MHJ,. 1995. Sterilization and Containment, p 553588. In Asenjo JA, Merchuk JC (ed). Bioreactor System Design. Marcel Dekker, Inc., New York, New York.
34. Vesley D,. 1986. Decontamination, sterilization, disinfection, and antisepsis in the microbiology laboratory, p 182198. In Miller BM (ed in chief). Laboratory Safety: Principles and Practices. American Society for Microbiology, Washington, D.C.
35. Neeleman R. 2010. GMO containment risks evaluation of single-use bioreactors. Xendo Process 2010:128.

Tables

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Table 1.

Citation: Petuch B. 2017. Biosafety in the Pharmaceutical Industry, p 585-595. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch31

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