Biotechnology companies are now quite convinced of the advantages of stirred tank disposable bioreactors for their manufacturing. The economics and advantages are so compelling that in a few years we could see the universal use of these equipments in all new production lines. Also, the FDA has accepted now, for more than one year, investigational new drug applications using these new equipments.
Large scale means upwards of forty and up to two-thousand litre working volume ranges and higher, although beyond two-thousand litres, the traditional stainless steel bioreactor is still preferred.
The fully-installed capital cost to put a single-use system, is double that of disposable systems, including utilities. Installation time is one-third in the case of one-use reactors. The need for cleaning validation is eliminated, thus reducing costs even more and improving the opportunity of changeover in facilities that are multiproduct. Stainless steel reactors require many hours of cleaning, lots of water and cleaning products, and agents to be ready to use, which increases production time – and cost.
With time between batches also reduced, the output of a production facility can also be increased, thereby also reducing costs.
In the next decade, the workhorse bioreactor for the industry will be around two-thousand litres and not 10,000 to 20,000 litres, as it currently stands. Drugs are becoming more potent and niche markets are becoming smaller, which requires more specific, productive, and efficient processes. Disposable technology makes drug development in niche markets much more economical, since a major hurdle in the development of these personalized drugs is precisely the smaller size of the niche and thus the difficult justification of an investment by a manufacturer.
In short, both development and manufacturing of bio products using single-use technology is more economical when we look at the trend taking hold, where products are more focused and go to smaller and smaller niche markets.