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Biotechnology & the pharmaceutical industryWith the discovery and introduction of biotechnological drugs, the pharmaceutical industry is rapidly rising, changing and expanding. Biotechnological drugs are any medicines which are therapeutic proteins such as monoclonal antibodies, blood proteins and enzymes that are produced by a living form specifically to help fight disease.They are usually produced by microbial fermentation or by mammalian cell culture and are not synthetically produced. At this present time there are over 370 new biotechnology medicines in different stages of progress, with the cell cultures being grown under very strict conditions and are regularly maintained in large stainless steel fermentation vats. Making a biotechnology drug Producing drugs is a very complicated and a time consuming process with many years just being spent in actually identifying the therapeutic protein, the gene sequence, then has to be determined and a process has to be worked out using biotechnology to produce the molecules. Only after the method has been devised and scaled up can biotechnology medicines be made in large quantities. This is then achieved by transforming the host cell to contain the particular gene of interest and growing the cells in large stainless steel tanks. To get the cells to produce the target proteins they must be kept alive and stimulated through using precise culture conditions, temperature is very often a crucial part and in some cases can vary by no more than one degree. The acidity levels must also be carefully watched for even if they vary a small fraction the cells can easily die, the duration of time the cells have to be left for will depend on the protein produced and the organism. The proteins are also stringently tested having been isolated from the cultures, and are then formulated into active products. Currently, culture methods can take several years and due to this there are significant challenges and it is very expensive right now to manufacture a complex biotechnological medicine. At this moment in time manufacturing practices are facing a major global shortage, for the production of biotechnological medicines, with there being fewer than a dozen facilities worldwide which are actually capable of manufacturing biological medicine on a large scale. Another major problem lies in the capacity, as this promises to become more complex over the next decade. There are only 30 protein based medicines on the market today with the industries production capacity already being overstretched, with 99 protein based medicines now being in the late stages of human trials and are expected to hit the market soon the production facilities which are already struggling will only be stretched even further in the coming years. |
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