Growth hormone, human recombinant

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.]... 

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). 

J. L. Cleland and A. J. Jones, Stable formulations of recombinant human growth hormone and interferon-y for microencapsulation in biodegradable microspheres, Phar. Res, 13(10), 1464 (1996). 

Examples of the early application of recombinant DNA technology in medicine are the development of recombinant human growth hormone human insulin human interferons, thought to have anticancer activity in addition to antiviral activity interleukins (regulatory proteins from lymphocytes that are believed to be important in the treatment of immunodeficiency diseases and cancer) tumor necrosis factor epidermal and bone marrow progenitor cell growth factors and the production of vaccines (Table 12.1). 

Lastly, it has been shown that in rare cases trisulfide bridges (Cys-SSS-Cys) can be found as hydrophobic variants of recombinant proteins. The experimental mass of such a trisulfide-bridged peptide would be increased by 32 amu. Andersson et al.125 have described this phenomenon for recombinant human growth hormone during expression in E. coli. However, the receptor binding properties were not affected by this trisulfide modification. 

Andersson C., Edlund P.O., Gellerfors P, Hansson Y., Holmberg E., Hult C., Johansson S., Kordel J., Lundin R., Mendel-Hartvig I., Noren B., Wehler T., Wid-malm G., and Ohman J. (1996), Isolation and characterization of a trisulfide variant of recombinant human growth hormone formed during expression in Escherichia coli, Int. J. Peptide Protein Res. 47(4), 311-321. 

Bam, N.B., J.L. Cleland, J. Yang, M.C. Manning, J.F. Carpenter, R.F. Kelley, and T.W. Randolph. 1998. Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions. J Pharm Sci 87 1554—1559. 

McNerney, T. M., Watson, S. K., Sim, J. H., and Bridenbaugh, R. L. (1996). Separation of recombinant human growth hormone from Escherichia coli cell pellet extract by capillary zone electrophoresis./. Chromatogr. A 744, 223 — 229. 

Dupin, P., Galinou, R, and Bayol, A. (1995). Analysis of recombinant human growth-hormone and its related impurities by capillary electrophoresis. /. Chromatogr. A 707, 396-400. 

K Shimura, BL Karger. Affinity probe capillary electrophoresis Analysis of recombinant human growth hormone with a fluorescent-labeled antibody fragment. Anal Chem 66 9-15, 1994. 

Frenz et al. applied the concept of trace enrichment to the tryptic digest of recombinant human growth hormone (rhGH). One of the innovations they introduced [39] was to directly monitor the... 

Table 8.8. Recombinant human growth hormone (rhGH) preparations approved for general medical...

Figure 8.14. Production of recombinant human growth hormone (rhGH) in E. coli (as an intracellular protein). Subsequent to fermentation, the cells are collected by centrifugation or filtration. After homogenization, nucleic acids and some membrane constituents are precipitated by the addition of polyethyleneimine. Ammonium sulphate precipitation of the supernatant concentrates the crude rhGH preparation. Chromatographic purification follows, as illustrated...

Similarly, concern about minute amounts of contaminants co-purified with human growth hormone extracted from brain tissues, which could lead to the development of Jacob-Kreutzfeld syndrome, inevitably resulted in the development of recombinant human growth hormone. Inactivated hepatitis B particles isolated from hepatitis B-positive patients were originally used to prevent hepatitis B virus infection, but a small fraction of individuals became infected through vaccination. When the hepatitis B surface antigen was... 

Fine, R.N., E.C. Kohaut, D. Brown, and A.J. Perlman, Growth after recombinant human growth hormone treatment in children with chronic renal failure report of a multicenter randomized double-blind placebo-controlled study. Genentech Cooperative Study Group. J Pediatr, 1994.124(3) 374-82. 

Table 37-4 Clinical Uses of Recombinant Human Growth Hormone. ...

Type IV poly(ortho esters) are very similar in structure to type II poly(ortho esters), but they do not need to have excipients in the formulation due to the incorporation of no acidic moieties in the polymer backbone (Ng et al. 1997). Rods of poly(ortho ester) loaded with recombinant human-growth hormone and bovine serum albumin have been created. The rods are the products of polymer-protein mixture extrusion at a temperature between 50° and 70°C. Particles have also been produced from these rods (Heller et al. 2000). The size of these particles, >106 pm, was much larger than would be expected to be absorbed by the gastrointestinal lining (Florence 1997). If the particle size can be reduced, this type of polymer system may be made to be acceptable for oral administration. 

Bam NB, Cleland JL, Randolph TW. Molten globule intermediate of recombinant human growth hormone stabilization with surfactants. Biotechnol Prog 1996 12(6) 801—809. 

Effects of recombinant human growth hormone (GH) on bone and intermediary metabolism in patients receiving chronic glucocorticoid treatment with suppressed endogenous GH response to GH-releasing hormone. J Clin Endocrinol Metab 1995 80(l) 122-9. 

This disease develops when an abnormal prion protein present in the cadaveric material induces a cascade of conformational changes in host protein. Creutzfeldt-Jakob disease in recipients of somatropin differs from the sporadic form, in that it usually presents with cerebellar signs rather than cognitive impairment, and also in the prominence of prion protein amyloid plaques in nervous tissue (18). In a review, 139 cases of Creutzfeldt-Jakob disease were identified worldwide in people treated with cadaveric somatropin before recombinant human growth hormone became available in the mid-1980s (19). The prevalence of this fatal neurodegenerative condition in recipients of somatropin ranges from 0.3% in the USA to 4.4% in France. Creutzfeldt-Jakob disease has been reported to start at 4-30 years after therapy with cadaveric somatropin (18), so that further cases are anticipated and continue to be reported (20). 

Weaver JU, Monson JP, Noonan K, John WG, Edwards A, Evans KA, Cunningham J. The effect of low dose recombinant human growth hormone replacement on regional fat distribution, insulin sensitivity, and cardiovascular risk factors in hypopituitary adults. J Clin Endocrinol Metab 1995 80(1) 153—9. 

Yeo AL, Levy D, Martin FC, Sonksen P, Sturgess I, Wheeler MM, Young A. Frailty and the biochemical effects of recombinant human growth hormone in women after surgery for hip fracture. Growth Hormone IGF Res 2003 13 361-70. 

Bercu BB, Murray FT, Frasier SD, Rudlin C, O Dea LS, Brentzel J, Hanson B, Landy H. Long-term therapy with recombinant human growth hormone (Saizen) in children with idiopathic and organic growth hormone deficiency. Endocrine 2001 15(l) 43-9. 

Olgaard K, Meeuwisse GW, Rix M, Pedersen FB. 61. Recombinant human growth hormone treatment, using two dose regimens in children with chronic renal fail- 62. ure—a report on linear growth and adverse effects. J Pediatr Endocrinol Metab 2002 15(5) 577-88. 63. 

Rosenfalck AM, Maghsoudi S, Fisker S, Jorgensen JO, Christiansen JS, Hilsted J, Volund AA, Madsbad S. The 68. effect of 30 months of low-dose replacement therapy with recombinant human growth hormone (rhGH) on insulin... 

Lo JC, Mulligan K, Noor MA, Schwarz JM, Halvorsen RA, Grunfeld C, Schambelan M. The effects of recombinant human growth hormone on body composition and glucose metabolism in HIV-infected patients with fat accumulation. J Clin Endocrinol Metab 2001 86(8) 3480-7. 

Yap HK, Loke KY, Murugasu B, Lee BW. Subclinical activation of lupus nephritis by recombinant human growth hormone. Pediatr Nephrol 1998 12(2) 133-5. 

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