Hormones recombinant

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

Follicle-stimulating hormone (human clone lambda 15B beta-subunit protein moiety reduced [CAS for beta subunit] Follicle-stimulating hormone, recombinant [SY] rhFSH [SY]... 

Thymopentin alfa for injection [FDA] Thyroid-stimulating hormone, recombinant [SY]... 

Thyrotrophin is native thyroid-stimulating hormone. Recombinant human thyrotrophin is called thyrotropin. 

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. 

Here, an overview of biopharmaceutical products thus far approved (within the EU and US at least) is presented. The products have been grouped into nine categories recombinant blood factors, recombinant thrombolytics, recombinant insulins, additional recombinant hormones, recombinant hematopoietic growth factors, recombinant IFNs and ILs, recombinant vaccines, monoclonal and engineered antibodies, and additional biopharmaceuticals (e.g., cell therapy, gene therapy, siRNA). 

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. 

Some of these compounds could be considered as dietary additives, but various other terms, including pesticides, can also be used. They can have beneficial effects on the environment and this aspect will be discussed later. The ionophore monensin, which is an alicyclic polyether (Figure 1), is a secondary metabolite of Streptomyces and aids the prevention of coccidiosis in poultry. Monensin is used as a growth promoter in cattle and also to decrease methane production, but it is toxic to equine animals. " Its ability to act as an ionophore is dependent on its cyclic chelating effect on metal ions. ° The hormones bovine somatotropin (BST) and porcine somatotropin (PST), both of which are polypeptides, occur naturally in lactating cattle and pigs, respectively, but can also be produced synthetically using recombinant DNA methods and administered to such animals in order to increase milk yields and lean meat production. "... 

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.]... 

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