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Chapter 47 : Scale-Up of Microbial Fermentation Process

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Abstract:

This chapter covers a broad scope of issues related to microbial fermentation process scale-up and describes specific steps to plan and execute a scale-up project. The purpose of a seed train is to propagate cells to a desired mass for inoculation into the production bioreactor. The traditional seed train includes thawing a vial and inoculating into shaker flasks for a certain number of stages with increasing flask sizes, and may include stainless steel reactors. The essence of scale-up of a fermentation process is to demonstrate fermentation production at large scale resulting in the same productivity and quality as that developed at small scale. A section of the chapter discusses specifically the scale-up of the bioreactor operational parameters such as agitation, airflow rate, and cooling capability based on small-scale data. At large scale, large amounts of bulk raw materials are expected. Their transportation, delivery, handling, and storage are to be considered and planned prior to scale-up. Scale-up projects often require implementation of new equipment or modification of existing equipment. A unique requirement for commercial biopharmaceutical process scale-up is process validation. With the tremendous diversity of organisms and products in industrial fermentation, a precise and one-size-fits-all strategy for scale-up is not practical. The keys for scale-up are to achieve project goals, produce desired product with acceptable quality and yield, and fully understand and control operational risks at large-scale manufacturing.

Citation: Yang X. 2010. Scale-Up of Microbial Fermentation Process, p 669-675. In Baltz R, Demain A, Davies J, Bull A, Junker B, Katz L, Lynd L, Masurekar P, Reeves C, Zhao H (ed), Manual of Industrial Microbiology and Biotechnology, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816827.ch47

Key Concept Ranking

Escherichia coli
0.48549184
Fermentation
0.48274335
pH Control
0.4308888
0.48549184
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Figures

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FIGURE 1

A typical microbial seed train.

Citation: Yang X. 2010. Scale-Up of Microbial Fermentation Process, p 669-675. In Baltz R, Demain A, Davies J, Bull A, Junker B, Katz L, Lynd L, Masurekar P, Reeves C, Zhao H (ed), Manual of Industrial Microbiology and Biotechnology, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816827.ch47
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References

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1. Berge, M.,, S. Bhargava,, R. Georgescu, and, X. Yang. 2008. Leveraging fermentation heat transfer data to better understand metabolic activity. BioPharm Int. 21:27.
2. Garcia-Ochoa, F., and, E. Gomez. 2009. Bioreactor scale-up and oxygen transfer rate in microbial processes: an overview. Biotechnol. Adv. 27:153176.
3. Junker, B. H. 2004. Scale-up methodologies for Esch-erichia coli and yeast fermentation process. J. Biosci. Bioeng. 97:347364.
4. Schmidt, F. R. 2005. Optimization and scale up of industrial fermentation processes. Appl. Microbiol. Biotechnol. 68:425435.
5. Yang, X. 2008. Large-scale microbial production technology for human therapeutic products, p. 329362. In E. S. Langer (ed.), Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-Up Production, 2nd ed. ASM Press and BioPlan Associates, Washington, DC.
6. Yang, X., and, L. Cui. 2004. Microbial process development for biopharmaceuticals. BioProcess Int. 2:3239.

Tables

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TABLE 1

An example of the parameters considered in fermentation scale-up

Citation: Yang X. 2010. Scale-Up of Microbial Fermentation Process, p 669-675. In Baltz R, Demain A, Davies J, Bull A, Junker B, Katz L, Lynd L, Masurekar P, Reeves C, Zhao H (ed), Manual of Industrial Microbiology and Biotechnology, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816827.ch47

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