Biosynthetic human growth hormone

Nielsen, R. G., Riggin, R. M., and Rickard, E. C., Capillary zone electrophoresis of peptide fragments from trypsin digestion of biosynthetic human growth hormone, /. Chromatogr., 480, 393, 1990. 

Although gradient elution is generally required for RPLC separations of proteins, isocratic elution can be successful in some instances. For example, isocratic elution has been used for the determination of purity of production batches of biosynthetic human growth hormone (HGH).42 The method was used to... 

Figure 4.12 Analysis of biosynthetic human growth hormone by isocratic reversed-phase chromatography. To generate all possible degradation products, a production lot of HGH was exposed to 40°C. The profile of the unstressed HGH is shown in the upper trace. (Reproduced from R.M. Riggin, G.K. Dorulla, and DJ. Miner, Anal. Biochem., 167 199 [1987]. With permission from Elsevier Science.)...

Performance parameters were established for the use of capillary zone electrophoresis (CZE) in the characterization of biosynthetic human growth hormone (hGH). 

The establishment of a physicochemical potency assay for biosynthetic human growth hormone provides an interesting example of an approach for validation of such assays. The hypophysectomized rat growth promoting assay used tradionally has a precision of approximately 15-20% RSD, which is clearly not adequate for controlling well-characterized products. In order to select a suitable assay to replace the in-vivo bioassay, the biopotencies... 

Ilium, L., Faraj, N., Davis, S., Johansen, B., and O Hagan, D. (1990), Investigation of the nasal absorption of biosynthetic human growth hormone in sheep Use of a bioadhesive microsphere delivery system, Int. J. Pharm., 63,207-211. 

Bowsher R, Apathy J, Ferguson A, Riggin RM, Henry DP. Cross-reactivity of monomeric and dimeric biosynthetic human growth hormone in commercial immunoassays. CHn Chem 1990 36 362-6. 

Rougeot C, Marchand P, Dray E, et al. Comparative study of biosynthetic human growth hormone immunogenicity in growth hormone deficient children. Horm Res 1991 35 76-81. 

Both Eli Lilly and Company and Genentech Company gained regulatory approval to market their formulations of biosynthetic human growth hormone, having completed subchronic toxicity studies with a maximiun duration of 90 days in rats and monkeys (Table 7.3). The rhesus monkey was considered to be the most relevant model due to the homology of the human and monkey growth hormones. 

Becker, G.W., Bowsher, R.R., Mackellar, W.C., et al. (1987) Chemical, physical, and biological characterization of a dimeric form of biosynthetic human growth hormone. Biotechnology and Applied Biochemistry, 9, 478 87. 

Hintz, R.L., R.G. Rosenfeld, D.M. Wilson, A. Bennett, J. Finno, B. McClellan, and R. Swift, Biosynthetic methionyl human growth hormones is biologically active in adult man. Lancet, 1982.1(8284) 1276-9. 

Somatotropin (growth hormone GH) is a pituitary somatotrophic linear peptide hormone of 191 residues. The name somatotropin is used for human growth hormone (HGH), which was isolated from the pituitary glands of cadavers. This when used to treat short stature (dwarfism) brought with it the risk of acquiring Creutzfeldt-Jakob disease through contamination. It is now replaced in many countries by somatropin, which is a biosynthetic form of human growth hormone without this liability. 

Jorgensen K D, Monrad J D, Brondum L, et al. (1988). Pharmacokinetics of biosynthetic and pituitary human growth hormones in rats. Pharmacol. Toxicol. 63 129-134. 

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