The use of disposable bioprocessing components began with the use of plastic bags designed for buffer preparation and very swiftly moved to disposable bioreactor bags on platforms. Now a considerable range of products for cell culture in upstream and downstream operations of the reactor is available.
A completely disposable bioprocess stream is now thought possible and perhaps will be available in the near future. The challenges ahead are mainly in the areas of biosensors and chromatographic purification. Progress in the use of these disposable systems is on the rise. The ease of use, flexibility, cost savings, and environmental convenience make the shift toward disposable bioprocessing streams virtually unstoppable.
The ability to transition between products and projects without having to go through extensive cleaning and validation protocols is an important advantage that contract manufacturers especially have come to greatly appreciate. Also, the risk of cross-contamination between streams is enormously reduced.
The use of disposable components in bioprocessing also enables manufacturers to quickly scale up their production whenever necessary. For example, with the recent so-called swine flu quasi-pandemic, the need for higher production of flu vaccine at a time of emergency was suddenly painfully evident. Disposable bioprocessing manufacturing components make it possible for a plant to transition from one level of production to another with ease.
Pharmaceutical consultancy in these areas has grown by leaps and bounds as more and more manufacturers wish to enable their plants with these new technologies. Medium and small – some boutique-sized – pharmaceutical companies had been blazing the trail in these initiatives for years as they attempted to bridge the gap of competitiveness with big pharma. However, given the recent complexities brought by lower margins in the pharmaceutical market, it is the big pharma firms who are pushing for faster improvements in disposables.
It remains to be seen how much more speed can be put into developments within this year, but it is clear that the lower risk, lower cost, and faster transitions that are possible by adopting the use of these new technologies is already revolutionizing the way pharmaceutical bioprocessing facilities are engineered and how production is planned. We are likely to see an accelerating trend toward smaller facilities with fewer production lines. Utilities at these facilities will be strategically placed so as to allow multiple configurations of storage tanks, reactors, filters, hoses and other common components. The time it will take for a bioprocessing facility to switch from one product to another or from one batch volume to a larger or smaller one, will become shorter and shorter as more disposable components become available. Indeed it seems disposables are here to stay.
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