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Single-Use Technology for Microbial Fermentation
Microbial fermentation processes are used for biomanufacturing of various drugs and vaccines, such as hormones, antibody fragments, and pneumococcal vaccine. Stirred-tank fermentors up to 100,000 L scale have traditionally been used in such microbial processes and their success has formed the general engineering foundation and principles of the design of bioreactors. The majority of today’s fermentation processes are performed in bioreactors constructed of traditional materials such as stainless steel. However, there is an increased interest in disposable technology to gain flexibility, save batch change-over time, and minimize cleaning and cleaning validation efforts.
To date, single-use stirred-tank bioreactors for mammalian and insect cell cultures have been successfully used in scales up to 2,000 L working volume and are installed in both clinical and commercial drug manufacturing facilities. However, for bioreactors to be utilized in microbial fermentation some engineering challenges needed to be addressed. For instance, fermentors had to be designed to handle very high metabolic rates and the high oxygen demands of some microbial cultures. By applying general bioengineering principles and designs, high oxygen transfer rates can be achieved also in disposable fermentors. Augmented designs and operational methods compensate for the low heat transfer rates in these systems. Although pressurizable single-use stirred-tank fermentors are within the realm of the technical feasibility, this feature might not be necessary as sufficient oxygen transfer can be achieved through a variety of mechanical and process control designs and techniques.
For more information on the use of single-use in microbial fermentation, please see:
Cell Culture Dish – “Single-use Technology for Microbial Fermentation”