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Chapter 32 : Biosafety Considerations for Large-Scale Processes

Authors: Mary L. Cipriano1, Marian Downing2, Brian Petuch3
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Affiliations: 1: Abbott Laboratories, North Chicago, Illinois (retired); 2: Abbott Laboratories, North Chicago, Illinois (retired); 3: Global Safety & Environment, Merck, West Point, Pennsylvania
Content Type: Reference
Publication Year: 2017

Category: Applied and Industrial Microbiology; Clinical Microbiology

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Abstract:

The notion of scale-up or large-scale processing of microorganisms is currently associated with recombinant DNA (rDNA) technology, but in fact it has been common practice for many years. Microorganisms have been scaled up for the manufacture of foods and beverages for centuries. In the past hundred years, the large-scale production of antibiotics, vaccines, and biological products has become commonplace. The relative numbers of laboratory-acquired infections from the production environment are extremely low, approximately 3.4% of the total numbers documented (1). Part of the reason for these low numbers may be the reduction in virulence of the cultured organism, but they are most likely attributable to the extensive use of primary and secondary containment barriers, i.e., containment equipment and facilities, which are generally required to maintain the integrity of the product.

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
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Biosafety Considerations for Large-Scale Processes
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Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
/content/10.1128/9781555819637.ch32.ch32fig1
Figure 1

Sterilizable bioreactor. (Courtesy of New Brunswick Scientific Co.)

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10.1128/9781555819637/9637ch32fig1.gif
Image of Figure 1
Figure 1

Sterilizable bioreactor. (Courtesy of New Brunswick Scientific Co.)

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
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Figure 2

Single-use, stirred-tank bioreactor. (Courtesy of New Brunswick Scientific Co.)

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10.1128/9781555819637/9637ch32fig2.gif
Image of Figure 2
Figure 2

Single-use, stirred-tank bioreactor. (Courtesy of New Brunswick Scientific Co.)

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
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Figure 3

Sampling assembly on a bioreactor. (Courtesy of New Brunswick Scientific Co.)

10.1128/9781555819637/9637ch32fig3_thmb.gif
10.1128/9781555819637/9637ch32fig3.gif
Image of Figure 3
Figure 3

Sampling assembly on a bioreactor. (Courtesy of New Brunswick Scientific Co.)

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
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Figure 4

Sterilizable sampling probes. (Courtesy of Merck & Co.)

10.1128/9781555819637/9637ch32fig4_thmb.gif
10.1128/9781555819637/9637ch32fig4.gif
Image of Figure 4
Figure 4

Sterilizable sampling probes. (Courtesy of Merck & Co.)

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
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References

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1. Harding AL, Byers KB, . 2006. Epidemiology of laboratory-associated infections, p 53– 77. In Fleming DO, Hunt DL (ed), Laboratory Safety: Principles and Practices, 4th ed. ASM Press, Washington, D.C.
2. Advisory Committee on Dangerous Pathogens . 1995. Categorization of Biological Agents According to Hazards and Categories of Containment, 4th ed. Her Majesty's Stationery Office, London, United Kingdom.
3. Advisory Committee on Dangerous Pathogens . 1998. The Large Scale Contained Use of Biological Agents. Her Majesty's Stationery Office, London, England.
4. Public Health Agency of Canada . 2015. Canadian Biosafety Standards and Guidelines, 2nd ed. Health and Welfare Canada, Ottawa, Canada.
5. National Institutes of Health . 2013. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) , as amended.
6. Organisation for Economic Co-operation and Development . 2000. Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work. OECD Publications, Paris, France.
7. Organisation for Economic Co-operation and Development . 2009. Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. Off J Eur Union L 125 : 75– 97.
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9. Prime Minister . 1991. Guidelines for Recombinant DNA Experiments. Ministry of Health, Tokyo, Japan.
10. World Health Organization . 2004. Laboratory Biosafety Manual, 3rd ed. World Health Organization, Geneva, Switzerland.
11. World Health Organization . 2003. Guidelines for the Safe Production and Quality Control of IPV Manufactured from Wild Polio Virus. World Health Organization, Geneva, Switzerland.
12. McGarrity GJ, Hoerner CL, . 1995. Biological safety in the biotechnology industry, p 119– 129. In Fleming DO, Richardson JH, Tulis JJ, Vesley D (ed), Laboratory Safety: Principles and Practices, 2nd ed. ASM Press, Washington, D.C.
13. American Institute of Chemical Engineers (AICE) . 2011. Guidelines for Process Safety in Bioprocess Manufacturing Facilities. John Wiley & Sons, Inc, Hoboken, New Jersey.
14. Bailey JE, Ollis DF . 1977. Biochemical Engineering Fundamentals. McGraw Hill, New York, N.Y.
15. Hambleton P, Melling J, Salusbury TT (ed). 1994. Biosafety in Industrial Biotechnology. Blackie, Glasgow, Scotland.
16. Liberman DF, Fink R, Schaefer F, . 1986. Biosafety in biotechnology, p 402– 408. In Solomon AL, Demain NA (ed), Industrial Microbiology and Biotechnology. American Society for Microbiology, Washington, D.C.
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18. Odum J . 1995. Fundamental guidelines for biotech multiuse facilities. Pharm. Eng. 15 : 8– 20.
19. Ghidoni DA, . 1999. HVAC issues in secondary containment, p 63– 72. In Richmond JY (ed), Anthology of Biosafety. American Biological Safety Association, Mundelein, Ill.
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21. World Health Organization . 2006. Biorisk Management. Laboratory Biosecurity Guidance. World Health Organization, Geneva, Switzerland.

Tables

Biosafety Considerations for Large-Scale Processes
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Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32
/content/10.1128/9781555819637.ch32.ch32tab1
Table 1.

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Table 1.

Citation: Cipriano M, Downing M, Petuch B. 2017. Biosafety Considerations for Large-Scale Processes, p 597-617. In Wooley D, Byers K (ed), Biological Safety: Principles and Practices, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819637.ch32

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