Humans insulin produced

NPH Isophane Human Insulin Suspension. NPH isophane insulin, also called Humulin N, Insulatard NPH Human, or Novolin N is an intermediate-acting form of human insulin produced by recombinant DNA techniques. Mixtures Humulin 70/30 and Novolin 70/30 contain 70% NPH isophane and 30% regular, whereas Humulin 50/50 contains 50% NPH isophane and 50% regular. It is adrninistered subcutaneously and should not be given intravenously. Absorption is delayed because the insulin is conjugated with protamine in a complex of reduced isoelectric solubiUty. Therapeutically, this preparation is probably comparable to purified porcine NPH insulin. However, human NPH insulin may have a slightly shorter duration of action than comparable purified porcine products. 

Human insulin produced by recombinant DNA technology was first approved for general medical use in 1982, initially in the USA, West Germany, the UK and The Netherlands. As such, it was the first product of recombinant DNA technology to be approved for therapeutic use in humans. From the 1990s on, several engineered insulin products (discussed later) also gained approval (Table 11.3). 

Humulin Recombinant human insulin produced in E. coli Identical to native human insulin EliLilly 1982 (USA)... 

Actrapid/Velosulin/ Monotard/ Insulatard/ Protaphane/ Mixtard/ Actraphane/ All contain recombinant human insulin produced in S. cerevisiae formulated as short/ intermediate/long acting product) Identical to native human insulin Novo Nordisk 2002 (EU)... 

Human insulin (pyr) recombinant human insulin produced in yeast Insulin B.P.jEur.P.jUSP insulin of bovine or porcine origin... 

Administration to market genetically engineered human insulin. 1982 The U.S. Food and Drug Administration approves the first genetically engineered drug, a form of human insulin produced by bacteria. 

Human Extended Insulin Zinc Suspension. Ultralente Humulin U is a long-acting form of human insulin produced by recombinant DNA techniques. It is administered subcutaneously and should not be given intravenously. The time course of this preparation is similar for onset of activity but shorter for maximum activity and duration of action compared with ultralente preparations of animal origin. Insulins of the lente series can be mixed in any proportion to obtain the desired dose and modified activity. 

Baker, R. S., Schmidtke, J. R., Ross, J. W., and Smith, W. C. (1981). Preliminary studies on the immunogenicity and amount of Escherichia coli polypeptides in biosynthetic human insulin produced by recombinant DNA technology. Lancet 2(8256), pp. 1139-1142. 

Insulin is a complex protein molecule produced by the pancreas in all vertebrates. This hormone regulates carbohydrate metabolism. Inability to produce insulin results in diabetes mellitus. Diabetes is treated by injections of insulin. Given the law of definite proportion, would you expect any differences in chemical activity between human insulin extracted from pancreatic tissue and human insulin produced by genetically engineered bacteria Why or why not ... 

Human insulin produced by rDNA is marketed by Eli Lilly and Company, Indianapolis, under the trade name Humulin. This was the first rDNA therapeutic to gain EDA approval in October, 1982 (PMA Survey Report, 1991). 

It is now 22 years since approval of hu-mulin (recombinant human insulin), produced in Escherichia coli and developed by Genentech in collaboration with EH Lilly [1]. Lilly received marketing authorization in the US for the product in 1982. This marked the true beginning of the biopharmaceutical industry. Currently some 142 biopharmaceuticals have gained approval for general human use in the EU and/or US (see also Part II, Chapter 4, Part VII,... 

There is no cure for diabetes. However, when the problem is the result of the inability to produce active insulin, blood glucose levels can be controlled moderately well by the injection of either animal insulin or human insulin produced from the cloned insulin gene. Unfortunately, one or even a few injections of insulin each day cannot mimic the precise control of blood glucose accomplished by the pancreas. 

A 68-year-old man with type 2 diabetes treated with insulin and oral hypoglycemic agents developed pruritic plaques of more than 15 cm diameter at the site of his insulin injections. Skin biopsy showed an Arthus type reaction. Various insulin therapies, including insulin glargine, insulin detemir, and human insulin, produced the same response. Intra-dermal tests were positive to a variety of insulins and protamine. He was desensitized using subcutaneous human insulin and orally fexofenadine 180 mg bd and was then successfully treated with insulin glargine. The fexofenadine was stopped 6 months later. 

The treatment of type 1 diabetes is the subcutaneous injection of insulin, as insulin cannot be administered orally because it would be broken down in the stomach due to the low pH. Initially, animal insulin was used in the treatment of diabetes, since bovine and porcine insulin are structurally similar to human insulin. Nowadays, most of the insulin used in the treatment of diabetes is human insulin produced via recombinant DNA (see Ch. 27). There are a number of insulin formulations available, e.g. short-, intermediate- or long-acting and biphasic (a mixture short- and intermediate-acting insulin), and these are described in more detail in Chapter 27. There is a range of therapy protocols indicated, based on the individual condition of the patient. 

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