Biopharmaceuticals — What Is Their Real Potential?
a Institute of Chemical Technology, Prague, b Zentiva Co., Prague
The current and future situation in the field of biopharmaceuticals is reviewed. The position of biopharmaceuticals on pharmaceutical market is still strengthening. Biopharmaceuticals cover many therapeutic areas involving treatment of cancer, autoimmune diseases, diabetes, anemia, disorders associated with lack of some proteins (e.g. human growth hormone) and others. Production of therapeutic proteins has shifted to new biotechnologies such as recombinant DNA and hybridoma technologies for production of monoclonal antibodies. Different types of expression systems suitable for production of biopharmaceuticals are described and compared. Mammalian cells, which are currently the most often used production system for glycoproteins, have several disadvantages including high production costs. This is why several cheaper expression systems are now being explored as alternatives. Yeast, plant and insect expression systems provide a new approach and potential for reduction of cost of biopharmaceuticals. The expiration of patents on original biopharmaceuticals give a chance to develop production of new drugs - biosimilars. Production of biosimilars can also reduce the cost of biopharmaceuticals, but under the condition that the safety and efficiency of biosimilars are the same as those of the original products.
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