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Key Elements for Efficient Fermentation Process Optimization in Pharmaceutical Industry


For large- or small-scale fermentation, process optimization in some critical steps plays an important role in improving efficiency because it can directly affect the formation, concentration, and yield of a particular fermentation end product, thus affecting the overall economics.
Editor: Alex Green Last Updated: 04-Jul-2022

However, the improvement of fermentation process is frequently associated with a lot of challenges: it's expensive, laborious, open-ended, and time-consuming. There are many aspects requiring attention from CDMOs to obtain better outcomes. The article below explores different well-known elements that are vital in the whole fermentation process.


Upstream Process Optimization

Upstream process optimization is used for microbial fermentation to enhance the strains' manufacturing efficiency and capacity. It refers to the selection of microbial hosts (such as bacteria and fungi), strain improvement, and strain breeding.


As the very starting point of fermentation process, microbial strains are always regarded key factors that determine the success or failure of metabolite production, thus being paid special attention. The ideal strains are those with advantages of rapid growth, genetic stability, and reduction of cultivation costs. Traditionally, strain improvement can be achieved by mutation, selection, cloning, and genetic recombination, which requires multi-disciplinary knowledge in biotechnology , molecular biology, genetic engineering, and the design of creative screening procedures.


In addition to strain improvement, the cell's culture conditions can also decide the growth rate of microbes. Therefore, the optimization of culture conditions should be included as an essential strategy as well.


Other aspects, such as high-throughput cell sorting, expansion of cell culture volumes and densities, process design, and media development are also supposed to be allocated with corresponding investment.


Downstream Process Optimization

The downstream process (DSP) includes the separation and refinement of target products from the reaction broth, culture broth, or fermentation broth during the mass cultivation of microbial strains. Multiple steps are involved for the recovery and purification of interested products, inevitably leading to a large amount of cost. Therefore, DSP optimization is conducted mainly for cost control.


Diverse techniques are now used for distinctive purposes. For instance, proteins expressed by microbial strains can be recovered and purified using size-exclusion chromatography or membrane separation techniques. Whatever the technique applied is, the final goal comes to low cost, high yield, and high purity production of the target products.



With a surge in the need for fermented biologics, it's becoming super necessary to further optimize the fermentation process for increasing the profitability and competitiveness of biotech enterprises, most of which have already made some improvements in this field.