Traditional pharmaceutical drugs are relatively simple molecules that have been found primarily through trial and error to treat the symptoms of a disease or illness. Biopharmaceuticals are large biological molecules known as proteins and these target the underlying mechanisms and pathways of a malady; it is a relatively young industry. They can deal with targets in humans that are not accessible with traditional medicines. A patient typically is dosed with a small molecule via a tablet while a large molecule is typically injected.
Small molecules are manufactured by chemistry but large molecules are created by living cells: for example, bacteria cells, yeast cell, and animal cells.
Modern biotechnology is often associated with the use of genetically altered microorganisms such as E. coli or yeast for the production of substances like insulin or antibiotics. It can also refer to transgenic animals or transgenic plants, such as Bt corn. Genetically altered mammalian cells, such as Chinese Hamster Ovary (CHO) cells, are also widely used to manufacture pharmaceuticals. Another promising new biotechnology application is the development of plant-made pharmaceuticals.
Biotechnology is also commonly associated with landmark breakthroughs in new medical therapies to treat diabetes, hepatitis B, hepatitis C, cancers, arthritis, haemophilia, bone fractures, multiple sclerosis, and cardiovascular disorders. The biotechnology industry has also been instrumental in developing molecular diagnostic devices than can be used to define the target patient population for a given biopharmaceutical. Herceptin, for example, was the first drug approved for use with a matching diagnostic test and is used to treat breast cancer in women whose cancer cells express the protein HER2.
Modern biotechnology can be used to manufacture existing drugs more easily and cheaply. The first genetically engineered products were medicines designed to combat human diseases. To cite one example, in 1978 Genentech developed humanized insulin by joining its gene with a plasmid vector inserted into the bacterium Escherichia coli. Insulin, widely used for the treatment of diabetes, was previously extracted from the pancreas of bovines and pigs. It was very expensive and often elicited an unwanted immunogenic response. The resulting genetically engineered bacterium enabled the production of vast quantities of human insulin at low cost.
Since then modern biotechnology has made it possible to produce more easily and cheaply human growth hormone, clotting factors for hemophiliacs, fertility drugs, erythropoietin and other drugs.Most drugs today are based on about 500 molecular targets. Genomic knowledge of the genes involved in diseases, disease pathways, and drug-response sites are expected to lead to the discovery of thousands more new targets.[9]
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