Assessment of the quality and structural integrity of a complex glycoprotein mixture following extraction from the formulated biopharmaceutical drug product

Journal of Pharmaceutical and Biomedical Analysis

Volumn 54, Issue 1, 2011, Pages 27-36

  Liu, Cuihua ^a   Dong, Shiming ^a   Xu, Xiao Jin ^a   Yin, Yan ^a   Shriver, Zachary ^a   Capila, Ishan ^a   Myette, James ^a   Venkataraman, Ganesh ^a  

^a Momenta Pharmaceuticals Inc   (United States)

Author keywords

Active pharmaceutical ingredient; Drug substance; Follicle stimulating hormone (FSH); Follitropin alpha; Glycoprotein drug product; Gonal F ; Isolation; Structural integrity

Indexed keywords

FOLLITROPIN; GLYCAN; RECOMBINANT FOLLITROPIN;

ARTICLE; CONTROLLED STUDY; DRUG PURIFICATION; EXTRACTION; FRACTIONATION; GENE EXPRESSION SYSTEM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ISOLATION PROCEDURE; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN GLYCOSYLATION; PROTEIN STRUCTURE; QUALITY CONTROL; SOLUBILITY;

BIOLOGICAL PRODUCTS; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, ION EXCHANGE; FOLLICLE STIMULATING HORMONE; FOLLICLE STIMULATING HORMONE, HUMAN; GLYCOPROTEINS; GLYCOSYLATION; GONADOTROPINS; HUMANS; ISOELECTRIC FOCUSING; PHARMACEUTICAL PREPARATIONS; POLYSACCHARIDES; PROTEIN ISOFORMS; SPECTROMETRY, MASS, MATRIX-ASSISTED LASER DESORPTION-IONIZATION;

EID: 77957018087     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.07.044     Document Type: Article

References (28)

1. Kaneko Y., Nimmerjahn F., Ravetch J.V. Analysis of glycoprotein-derived oligosaccharides in glycoproteins detected on two-dimensional gel by capillary electrophoresis using on-line concentration method. Science 2006, 313:670-673.
2. Scallon B.J., Tam S.H., McCarthy S.G., Cai A.N., Raju T.S. Higher levels of sialylated Fc glycans in immunoglobulin G molecules can adversely impact functionality. Mol. Immunol. 2007, 44:1524-1534.
3. Bork K., Horstkorte R., Weidemann W. Increasing the sialylation of therapeutic glycoproteins: the potential of the sialic acid biosynthetic pathway. J. Pharm. Sci. 2009, 98:3499-3508.
4. Varki A. Sialic acids in human health and disease. Trends Mol. Med. 2008, 14:351-360.
5. Shinkawa T., Nakamura K., Yamane N., Shoji-Hosaka E., Kanda Y., Sakurada M., Uchida K., Anazawa H., Satoh M., Yamasaki M., Hanai N., Shitara K. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J. Biol. Chem. 2003, 278:3466-3473.
6. Abdel-Motal U., Wang S., Lu S., Wigglesworth K., Galili U. Increased immunogenicity of human immunodeficiency virus gp120 engineered to express Galalpha1-3Galbeta1-4GlcNAc-R epitopes. J. Virol. 2006, 80:6943-6951.
7. Dor F.J., Tseng Y.L., Cheng J., Moran K., Sanderson T.M., Lancos C.J., Shimizu A., Yamada K., Awwad M., Sachs D.H., Hawley R.J., Schuurman H.J., Cooper D.K. alpha1,3-Galactosyltransferase gene-knockout miniature swine produce natural cytotoxic anti-Gal antibodies. Transplantation 2004, 78:15-20.
8. Mandell R.B., Flick R., Staplin W.R., Kaniewski L.D., Carzoli A.K., Manuszak R.P., Wang J., Rossi G.R., Vahanian N.N., Link C.J. The alphaGal HyperAcute(R) Technology: Enhancing Immunogenicity of Antiviral Vaccines by Exploiting the Natural alphaGal-Mediated Zoonotic Blockade 2009, Zoonoses Public Health.
9. Dhume S.T., Saddic G.N., Anumula K.R. Monitoring glycosylation of therapeutic glycoproteins for consistency by HPLC using highly fluorescent anthranilic acid (AA) tag. Methods Mol. Biol. 2008, 446:317-331.
10. Oda R.P., Landers J.P. High-resolution glycoprotein analysis using capillary electrophoresis. Mol. Biotechnol. 1996, 5:165-170.
11. Kamoda S., Kakehi K. Capillary electrophoresis for the analysis of glycoprotein pharmaceuticals. Electrophoresis 2006, 27:2495-2504.
12. Geyer H., Geyer R. Strategies for analysis of glycoprotein glycosylation. Biochim. Biophys. Acta 2006, 1764:1853-1869.
13. Lo V.M., Hahn M.G., Hong N., Ogawa T., van Halbeek H. Complete assignment of the 1H NMR spectra of phytoalexin elicitor-active oligoglucosides. Carbohydr. Res. 1993, 245:333-345.
14. Fan Q.R., Hendrickson W.A. Assembly and structural characterization of an authentic complex between human follicle stimulating hormone and a hormone-binding ectodomain of its receptor. Mol. Cell. Endocrinol. 2007, 260-262:73-82.
15. Bassett R., Ceccarelli D., Crisci C., di Tria A.M., Mancinelli M., Martelli F., Mendola D., Pezzotti A. Comparative analytical characterization of two commercial human follicle-stimulating hormones extracted from human urine. Curr. Med. Res. Opin. 2005, 21:899-905.
16. Bassett R.M., Driebergen R. Continued improvements in the quality and consistency of follitropin alfa, recombinant human FSH. Reprod. Biomed. Online 2005, 10:169-177.
17. Yding Andersen C., Leonardsen L., Ulloa-Aguirre A., Barrios-De-Tomasi J., Moore L., Byskov A.G. FSH-induced resumption of meiosis in mouse oocytes: effect of different isoforms. Mol. Hum. Reprod. 1999, 5:726-731.
18. Zambrano E., Zarinan T., Olivares A., Barrios-de-Tomasi J., Ulloa-Aguirre A. Receptor binding activity and in vitro biological activity of the human FSH charge isoforms as disclosed by heterologous and homologous assay systems: implications for the structure-function relationship of the FSH variants. Endocrine 1999, 10:113-121.
19. Ulloa-Aguirre A., Timossi C., Damian-Matsumura P., Dias J.A. Role of glycosylation in function of follicle-stimulating hormone. Endocrine 1999, 11:205-215.
20. Baenziger J.U., Green E.D. Pituitary glycoprotein hormone oligosaccharides: structure, synthesis and function of the asparagine-linked oligosaccharides on lutropin, follitropin and thyrotropin. Biochim. Biophys. Acta 1988, 947:287-306.
21. Gray C.J. Molecular weight of human follicle stimulating hormone. Nature 1967, 216:1112-1113.
22. Mulders J.W., Derksen M., Swolfs A., Maris F. Prediction of the in vivo biological activity of human recombinant follicle stimulating hormone using quantitative isoelectric focusing. Biologicals 1997, 25:269-281.
23. Storring P.L., Gaines Das R.E., Mulders J.W., Halder M. Physicochemical methods for predicting the biological potency of recombinant follicle stimulating hormone: an international collaborative study of isoelectric focusing and capillary zone electrophoresis. Biologicals 2002, 30:217-234.
24. Fox K.M., Dias J.A., Van Roey P. Three-dimensional structure of human follicle-stimulating hormone. Mol. Endocrinol. 2001, 15:378-389.
25. Gervais A., Hammel Y.A., Pelloux S., Lepage P., Baer G., Carte N., Sorokine O., Strub J.M., Koerner R., Leize E., Van Dorsselaer A. Glycosylation of human recombinant gonadotrophins: characterization and batch-to-batch consistency. Glycobiology 2003, 13:179-189.
26. van de Wiel D.F., van Rijn P.A., Meloen R.H., Moormann R.J. High-level expression of biologically active recombinant bovine follicle stimulating hormone in a baculovirus system. J. Mol. Endocrinol. 1998, 20:83-98.
27. Borromeo V., Amsterdam A., Berrini A., Gaggioli D., Dantes A., Secchi C. Characterization of biologically active bovine pituitary FSH purified by immunoaffinity chromatography using a monoclonal antibody. Gen. Comp. Endocrinol. 2004, 139:179-189.
28. Mottershead D.G., Pulkki M.M., Muggalla P., Pasternack A., Tolonen M., Myllymaa S., Korchynskyi O., Nishi Y., Yanase T., Lun S., Juengel J.L., Laitinen M., Ritvos O. Characterization of recombinant human growth differentiation factor-9 signaling in ovarian granulosa cells. Mol. Cell. Endocrinol. 2008, 283:58-67.