Almosta century ago, diabetic patients who have high glucose level due to impairedinsulin have found good news as Banting and Best discovered the treatment thatcan control diabetes which is called insulin. This insulin was derived frompancreas glands of animals such as bovine and porcine. Pancreas’ islet ofLangerhans consist of Beta cells which has the ability to produce and secretehormone that can act by regulating the use and storage of food especiallycarbohydrates (Ferrer-miralles et al., 2009). In otherwords, Beta cells of pancreas can store and release insulin which can controland reduce blood glucose.Interestingly,the insulin which derived from bovine and porcine has almost similarcomposition with human insulin.
There are only 3 amino acids sequences whichmake the human insulin slightly different from bovine. Due to this slightdifference, some patients’ immune systems will produce antibodies that actagainst it. These antibodies will neutralise the insulin’s action which finallylead to inflammatory responses at injection sites. On top of that, there arealso some issues regarding the long term complications of regular injection offoreign substance like bovine and porcine derived insulin as well as thedeclining of the production of animal derived insulin. All of these factorshave opened the eyes of the researchers to ponder and consider in synthesizingHumulin. Humulin which is the human derived insulin can produce by insertingthe insulin gene into suitable vector such as Escherichia coli (E.coli) bacterial cell (Thimet al.
, 1986). This invention has led to theproduction of insulin that is chemically identical to the natural insulinproduced by human. The method used to achieve this valuable discovery is calledrecombinant DNA technology.
TheDNA cloning technique can be defined as a method to produce identical copies ofa piece of DNA. It was invented by Herbert Boyer and Stanley Cohen. Thistechnique indicates the birth of genetic engineering which allow genes to be transferredamong biological species in easy way (Cohenet al., 1973). The concept of recombinant DNA technology hasproved that it is possible to produce new genetic combination. It can be doneby joining the DNA molecules from two different species together which laterwill be inserted to the host organism. Then, the host organism will produce theidentical copies of the gene. This brilliant discovery led to development ofseveral recombinant proteins with therapeutic applications such as insulin andgrowth hormone.
Human insulin was the first licensed drug that is produce byusing recombinant DNA technology. This human insulin was developed in 1982 by acompany named Genentech and it is licensed as well as marketed by pharmaceuticalcompany called Eli Lily.EliLily and Company is an American global pharmaceutical company which discovers,develops, manufactures and markets a lot of ethical drugs for a wide variety ofhuman ailments. In 1921, Eli Lily has introduced the world’s first commercialinsulin.
Their effort in discovering and developing diabetes drugs is successfulas they become the leading producer of products for those with diabetes. Thehighest achievement of Eli Lily is being one of the first pharmaceuticalcompanies that produce human insulin using recombinant DNA including Humulin,Humalog and the first biosimilar insulin product to be approved in the UnitedStates which is Basaglar. Humulin R (regular) and Humulin N (NPH) whichproduced by Eli Lilly & Co are the first human healthcare product fromrecombinant DNA technology to reach the market. At present, insulin is being producedpredominantly by DNA recombinant technique in host organisms such as E. coli and Saccharomycescerevisiae for treatment of diabetic patients (Walsh,2005).