Heterogeneity of commercial recombinant human growth hormone (r-hGH) preparations containing a thioether variant

Journal of Pharmaceutical Sciences

Volumn 98, Issue 12, 2009, Pages 4511-4524

  Lispi, Monica ^a   Datola, Antonio ^a   Bierau, Horst ^a   Ceccarelli, Domenico ^a   Crisci, Carmelina ^a   Minari, Katia ^a   Mendola, Daniele ^a   Regine, Aniello ^a   Ciampolillo, Cinzia ^b   Rossi, Mara ^a   Giartosio, Carlo Emanuele ^a   Pezzotti, Anna Rita ^a   Musto, Raffaella ^a   Jone, Carl ^c   Chiarelli, Francesco ^d  

^a Merck Serono SpA   (Italy)

^b Istituto di Ricerche Biomediche Antoine Marxer SpA   (Italy)

^c MERCK SERONO S A   (Switzerland)

^d UNIVERSITY OF CHIETI   (Italy)

Author keywords

Bioactivity; Growth hormone; Immunogenicity; Posttranslational modification; Protein structure; Thioether

Indexed keywords

HUMAN GROWTH HORMONE; SULFIDE;

ARTICLE; BIOASSAY; CONTROLLED STUDY; DRUG ACTIVITY; DRUG EFFICACY; DRUG SAFETY; ELECTROSPRAY MASS SPECTROMETRY; HUMAN; MASS SPECTROMETRY; MEDICAL LITERATURE; PEPTIDE MAPPING; RECEPTOR BINDING;

EID: 71649087076     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21774     Document Type: Article

References (27)

1. Buchanan CR, Preece MA, Milner RD. 1991. Mortality, neoplasia, and Creutzfeldt-Jakob disease in patients treated with human pituitary growth hormone in the United Kingdom. BMJ 302:824-828.
2. Dorantes-Alvarez LM. 1990. Results of the treatment of growth hormone deficiency with methionine-somatotropin or recombinant somatotropin. Bol Med Hosp Infant Mex 47:369-371 (Article in Spanish).
3. Hepner F, Csaszar E, Roitinger E, Pollak A, Lubec G. 2006. Massspectrometrical analysis of recombinant human growth hormone Norditropin reveals amino acid exchange at M14-V14 rhGH. Proteomics 6:775-784. (Pubitemid 43260203)
4. Hepner F, Cszasar E, Roitinger E, Lubec G. 2005. Mass spectrometrical analysis of recombinant human growth hormone (Genotropin(R)) reveals amino acid substitutions in 2% of the expressed protein. Proteome Sci 3:1. (Pubitemid 43298282)
5. Charton E, Miller JH, Briancon F, Rautmann G. 2004. Capillary electrophoresis for the control of impurities of rDNA somatropin. Pharmeuropa Bio 1:47-58.
6. Dupin P, Galinou F, Bayol A. 1995. Analysis of recombinant human growth hormone and its related impurities by capillary electrophoresis. J Chromatog A 707:396-400.
7. Persson J, Andersen DC, Lester PM. 2005. Evaluation of different primary recovery methods for E. coli-derived recombinant human growth hormone and compatibility with further down-stream purification. Biotechnol Bioeng 90:442-451. (Pubitemid 40789913)
8. Jung C, Lee YP, Jeong YR, Kim JY, Kim YH, Kim HS. 2005. Characterization of N alpha-acetyl methionyl human growth hormone formed during expression in Saccharomyces cerevisiae with liquid chromatography and mass spectrometry. J Chromatog B Analyt Technol Biomed Life Sci 814:53-59. (Pubitemid 40017935)
9. Wurm FM. 2004. Production of recombinant protein therapeutics in cultivated mammalian cells. Nature Biotech 22:1393-1398. (Pubitemid 39482858)
10. Committee for Medicinal Products for Human Use. 2006. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. CHMP/BMWP/42832/2005.
11. Datola A, Richert S, Bierau H, Agugiaro D, Izzo A, Rossi M, Cregut D, Diemer H, Schaeffer C, Van Dorsselaer A, Giartosio CE, Jone C. 2007. Characterisation of a novel growth hormone variant comprising a thioether link between Cys182 and Cys189. Chem Med Chem 2:1181-1189.
12. Bayol A, Bristow A, Charton E, Girard M, Jongen P. 2004. Somatropin and its variants: structural characterization and methods of analysis. Pharmeuropa Bio 1:35-45.
13. Gellerfors P, Pavlu B, Axelsson K, Nyhlen C, Johansson S. 1990. Separation and identification of growth hormone variants with high performance liquid chromatography techniques. Acta Paediatr Scand Suppl 370:93-100. (Pubitemid 20342282)
14. Canova-Davis E, Baldonado IP, Moore JA, Rudman CG, Bennett WF, Hancock WS. 1990. Properties of a cleaved two-chain form of recombinant human growth hormone. Int J Pept Protein Res 35:17-24. (Pubitemid 20090563)
15. Karlsson G, Gellerfors P, Persson A, Noren B, Edlund PO, Sandberg C, Birnbaum S. 1999. Separation of oxidized and deamidated human growth hormone variants by isocratic reversed-phase high-performance liquid chromatography. J Chromatogr A 855:147-155. (Pubitemid 29413094)
16. Teshima G, Stults JT, Ling V, Canova-Davis E. 1991. Isolation and characterization of a succinimide variant of methionyl human growth hormone. J Biol Chem 266:13544-13547. (Pubitemid 21907383)
17. Battersby JE, Guzzetta AW, Hancock WS. 1994. Application of capillary highperformance liquid chromatography to biotechnology, with reference to the analysis of recombinant DNA-derived human growth hormone. J Chromatogr B Biomed Appl 662:335-342.
18. Chang SH, Teshima GM, Milby T, Gillece-Castro B, Canova-Davis E. 1997. Metal-Catalyzed Photooxidation of Histidine in Human Growth Hormone. Anal Biochem 244:221-227. (Pubitemid 27043317)
19. Canova-Davis E, Baldonado IP, Chloupek RC, Ling VT, Gehant R, Olson K, Gillece-Castro BL. 1996. Confirmation by mass spectrometry of a trisulfide variant in methionyl human growth hormone biosynthesized in Escherichia coli. Anal Chem 68:4044-4051. (Pubitemid 26393263)
20. Jespersen AM, Christensen T, Klausen NK, Nielsen F, Sorensen HH. 1994. Characterisation of a trisulphide derivative of biosynthetic human growth hormone produced in Escherichia coli. Eur J Biochem 219:365-373. (Pubitemid 24053651)
21. Andersson C, Edlund PO, Gellerfors P, Hansson Y, Holmberg E, Hult C, Johansson S, Kordel J, Lundin R, Mendel-Hartvig IB, Noren B, Wehler T, Widmalm G, Ohman J. 1996. Isolation and characterization of a trisulfide variant of recombinant human growth hormone formed during expression in Escherichia coli. Int J Pept Protein Res 47:311-321. (Pubitemid 26143854)
22. Jung C, Lee YP, Jeong YR, Kim JY, Kim YH, Kim HS. 2005. Characterization of N alpha-acetyl methionyl human growth hormone formed during expression in Saccharomyces cerevisiae with liquid chromatography and mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 814:53-59. (Pubitemid 40017935)
23. Horn MJ, Jones DB, Ringel SJ. 1941. Isolation of a new sulfur-containing amino acid (lanthionine) from sodium carbonate-treated wool. J Biol Chem 138:141-149.
24. Skottner A, Forsman A, Skoog B, Kostyo JL, Cameron CM, Adamafio NA, Thorngren KG, Hagerman M. 1988. Biological characterization of charge isomers of human growth hormone. Acta Endocrinol (Copenh) 118:14-21. (Pubitemid 18122076)
25. Becker GW, Tackitt PM, Bromer WW, Lefeber DS, Riggin RM. 1988. Isolation and characterization of a sulfoxide and a desamido derivative of biosynthetic human growth hormone. Biotechnol Appl Biochem 10:326-337.
26. Cunningham BC, Wells JA. 1993. Comparison of a structural and a functional epitope. J Mol Biol 234:554-563.
27. Pitukcheewanont P, Schwarzbach L, Kaufman FR. 2002. Resumption of growth after methionyl-free human growth hormone therapy in a patient with neutralizing antibodies to methionyl human growth hormone. J Pediatr Endocrinol Metab 15:653-657. (Pubitemid 34704826)