Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line

Journal of Clinical Pharmacology

Volumn 54, Issue 11, 2014, Pages 1299-1307

  Olsson, Håkan ^a   Sandström, Rikard ^a   Grundemar, Lars ^a  

^a Ferring Pharmaceuticals AS   (Denmark)

Author keywords

bioavailability; human cell line; pharmacodynamics; pharmacokinetics; recombinant FSH

Indexed keywords

ESTRADIOL; INHIBIN B; RECOMBINANT FOLLITROPIN; FOLLITROPIN; RECOMBINANT PROTEIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHO CELL LINE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG CLEARANCE; EDEMA; ELIMINATION HALF-LIFE; FEMALE; HOT FLUSH; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; NORMAL HUMAN; PELVIC PAIN; PROTEIN EXPRESSION; REPEATED DRUG DOSE; SINGLE DRUG DOSE; VOLUME OF DISTRIBUTION; ANIMAL; CELL LINE; CRICETULUS; CROSSOVER PROCEDURE; GENETICS; HAMSTER; METABOLISM; RANDOMIZED CONTROLLED TRIAL; SPECIES DIFFERENCE; YOUNG ADULT;

ADULT; ANIMALS; CELL LINE; CHO CELLS; CRICETINAE; CRICETULUS; CROSS-OVER STUDIES; FEMALE; FOLLICLE STIMULATING HORMONE; HUMANS; RECOMBINANT PROTEINS; SPECIES SPECIFICITY; YOUNG ADULT;

EID: 84921982584     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.328     Document Type: Article

References (27)

1. Hillier SG,. Current concepts of the roles of follicle stimulating hormone and luteinizing hormone in folliculogenesis. Hum Reprod. 1994; 9: 188-191.
2. Simoni M, Weinbauer GF, Gromoll J, Nieschlag E,. Role of FSH in male gonadal function. Ann Endocrinol (Paris). 1999; 60: 102-106.
3. Butt WR, Ryle M, Shirley A,. Kinetic studies with 125I-labelled follicle-stimulating hormone. J Endocrinol. 1973; 58: 275-287.
4. Sebok K, Sairam MR, Cantin M, Mohapatra SK,. Distribution of follitropin and deglycosylated follitropin in the rat: a quantitative and radioautographic study. Mol Cell Endocrinol. 1987; 52: 185-197.
5. Emmanouel DS, Stavropolous T, Katz AI,. Role of the kidney in metbolism of gonadotropins in rats. Am J Physiol. 1984; 247: E786-E792.
6. Nisula BC, Blithe DL, Akar A, Lefort G, Wehmann RE,. Metabolic fate of human choriogonadotropin. J Steroid Beiochem. 1989: 733-737.
7. Pierce JG, Parsons TF,. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981; 50: 465-495.
8. Ulloa-Aguirre A, Timossi C, Damián-Matsumura P, Dias JA,. Role of glycosylation in function of follicle-stimulating hormone. Endocrine. 1999; 11: 205-215.
9. Ulloa-Aguirre A, Timossi C, Barrios-de-Tomasi J, Maldonado A, Nayudu P,. Impact of carbohydrate heterogeneity in function of follicle-stimulating hormone: studies derived from in vitro and in vivo models. Biol Reprod. 2003; 69: 379-389.
10. Goochee CF, Gramer MJ, Anderson DC, Bahr JB,. Rasmunsen JR The oligosaccharides of glycoproteins: bioprocess factors affecting oligosaccharide structure and their effect on glycoprotein properties. Biotechnology. 1991; 9: 1347-1355.
11. D'Antonio M, Borrelli F, Datola A, et al. Biological characterization of recombinant human follicle stimulating hormone isoforms. Human Reprod. 1999; 14: 1160-1167.
12. Zambrano E, Zarinan T, Olivares A, Barrios-de-Tomasi J, UlloaAguirre 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.
13. Barrios-De-Tomasi J, Timossi C, Merchant H, et al. Assessment of the in vitro and in vivo biological activities of the human follicle-stimulating isohormones. Mol Cell Endcrinol. 2002; 186: 189-198.
14. Loreti N, Fresno C, Barrera D, et al. The glycan structure in recombinant human FSH affects endocrine activity and global gene expression in human granulosa cells. Mol Cell Endocrinol. 2013; 366: 68-80.
15. de Leeuw R, Mulders J, Voortman G, Rombout F, Damm J, Kloosterboer L,. Structure-function relationship of recombinant follicle stimulating hormone (Puregon). Mol Hum Reprod. 1996; 2: 361-369.
16. Howles C,. Genetic engineering of human FSH (Gonal-F). Hum Reprod Update. 1996; 2: 172-191.
17. World Intellectual Property Organisation (WO 2009/127826 Al) Recombinant FSH including α 2,3 and α 2,6 sialylation.
18. Steelman SL, Pohley FM,. Assay of the follicle stimulating hormone based on the augmentation with human chorionic gonadotropin. Endocrinology. 1953; 53: 604-616.
19. le Cotonnec J-Y, Porchet HC, Beltrami V, Kahn A, Toon Rowland SM,. Clinical pharmacology of recombinant human follicle-stimulating hormone (FSH): part I. Comparative pharmacokinetics with urinary human FSH. Fertil Steril. 1994; 61: 669-678.
20. Loumaye E, Campbell R, Salat-Baroux J,. Human follicle-stimulating hormone produced by recombinant DNA technology: a review for clinicians. Hum Reprod Update. 1995; 1: 188-199.
21. le Cotonnec J-Y, Porchet HC, Beltrami V, Kahn A, Toon S, Rowland M,. Clinical pharmacology of recombinant human follicle-stimulating hormone: part II. Single dose and steady state pharmacokinetics. Fertil Steril. 1994; 61: 679-686.
22. Trinchar-Lugan I, Khan A, Porchet HC, Munafo A,. Pharmacokinetics and pharmacodynamics of recombinant human chorionic gonadotrophin in healthy male and female volunteers. Reprod Biomed Online. 2002; 4: 106-115.
23. le Cotonnec J-Y, Porchet HC, Beltrami V, Munafo A,. Clinical pharmacology of recombinant human luteinizing hormone: part II. Bioavailability of recombinant human luteinizing hormone assessed with an immunoassay and an in vitro bioassay. Fertil Steril. 1998; 69: 195-200.
24. Porter CJ, Charman SA,. Lymphatic transport of proteins after subcutaneous administration. J Pharm Sci. 2000; 89: 297-310.
25. Ballard BE,. Biopharmaceutical considerations in subcutaneous and intramuscular drug administration. J Pharm Sci. 1968; 57: 357-378.
26. Voortman G, Mannaerts BMJL, Huisman JAM,. A dose proportionality study of subcutaneously and intramuscularly administered recombinant human folliclestimulating hormone (Follistim/Puregon) in healthy female volunteers. Fertil Steril. 2000; 73 (6): 1187-1193.
27. Porchet HC, le Cotonnec J-Y, Loumaye E,. Clinical pharmacology of recombinant human follicle-stimulating hormone. III. Pharmacokinetic-pharmacodynamic modeling after repeated subcutaneous administration. Fertil Steril. 1994; 61: 687-695.