Growth hormone, recombinant

Chemical Class ENDO-growth hormone recombinant human peptide Clinical Pharmacology ... 

Somatropin [rDNA origin] for injection [FDA] Human growth hormone, recombinant [SY] hGH [SY]... 

Human Genome Project. 160 Human growth hormone, recombinant. 168. 175-176... 

GH assays now use mouse monoclonal antibodies, and some of these assays are able to discriminate GH variants. Most procedures use recombinant-derived GH for labeling with a tracer and calibration material. The latter is usually prepared gravimetricaUy and verified by comparison with an international reference preparation (IRP), such as the World Health Organization s (WHO s) international standard, IRP 80/505 human growth hormone recombinant (hGHr), which has a potency of 3.3IU/mg of r-hGH, or other standard preparations, such as WHO IRP 66/217 or 88/624. The assay diluent, however, can vary considerably from one assay to another and is a potential source of bias some commercial kits use phosphate-buffered saline, and others use horse, calf, or human serum. 

Therapeutics. Therapeutic materials represent a class of polypeptides that are a low volume, high value product. The production system need not be very efficient but the quaHty of the recombinant protein has to be extremely pure (33,34). Thus high cost mammalian production systems can be tolerated. However, some of the therapeutic proteins such as insulin, human growth hormone, interleukins, interferon, and streptokinase are produced microbially. 

Human growth hormone was originally manufactured by isolation of the natural product from human pituitaries and subsequent purification of the protein. Since 1985, manufacture of hGH has been almost exclusively by recombinant DNA technology. 

Human growth hormone is one of the largest selling therapeutic proteins produced by recombinant DNA technology. Annual worldwide sales increased from 130,000,000 in 1987 to 575,000,000 in 1992 (47). Upon approval of additional indications, the sales of hGH are expected to increase even more. 

One technology uses bovine somatotropin (bST) produced by recombinant technology (38). Somatotropin [9002-72-6] is a growth hormone. The bST-supplemented cows provide an increase in milk output per cow or an increased feed efficiency. Recombinant bST, also known as recombinant bovine growth hormone (rBGH) is the synthetic analogue of a natural hormone that increases milk production in cows (39). The use of recombinant technology was approved by the FDA in 1993. The Commission of the European Community has recommended that the moratorium on commercial use of BGH be delayed until the year 2000. 

FIGURE 2.10 Analytical SEC for determination of abnegates in preparations of recombinant human growth hormone using Superdex 75 HR 10/30. [Reproduced from Hagel (1993). with permission.]... 

The advantages of recombinant DNA technology are enormous, as the following example shows. Somatostatin is a hormone that inhibits the secretion of pituitary growth hormone. The researchers who first isolated somatostatin required nearly half a million sheep brairrs to produce 5 mg of the substance. Using a chemically synthesized gene, 9... 

Guerigan J.L. (Ed.) (1982) Insulins, Growth Hormone and Recombinant DNA Technology. New York Raven Press. 

Recombinant growth hormone therapy is the main pharmacologic treatment for growth hormone deficiency in both children and adults. 

Although comparative trials have not been conducted, recombinant growth hormone products appear to have similar efficacy for treating growth hormone deficiency. 

Biotechnology era beginning First recombinant DNA products Human insulin Human growth hormone Interferons, etc. Monoclonal antibodies Nucleotide blockage Growth in use of natural products and neutraceuticals... 

M. Mumenthaler, C. C. Hsu, and R. Pearlman, Feasibility study on spray-drying protein pharmaceuticals recombinant human growth hormone and tissue-type plasminogen activator, Pharm. Res, 11(1), 12 (1994). 

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