Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations
Different gonadotrophin preparations derived from human urine or manufactured by recombinant technology are currently used in clinical practice for the treatment of infertility. It has been widely assumed that gonadotrophin products manufactured by recombinant technology have better batch-to-batch c...
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Reproductive Healthcare Ltd
2005
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| Acceso en línea: | Registro en Scopus DOI Handle Registro en la Biblioteca Digital |
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| LEADER | 14399caa a22012377a 4500 | ||
|---|---|---|---|
| 001 | PAPER-22224 | ||
| 003 | AR-BaUEN | ||
| 005 | 20230518205346.0 | ||
| 008 | 190411s2005 xx ||||fo|||| 00| 0 eng|d | ||
| 024 | 7 | |2 scopus |a 2-s2.0-16844368185 | |
| 024 | 7 | |2 cas |a chorionic gonadotropin, 9002-61-3; human menopausal gonadotropin, 61489-71-2; recombinant follitropin, 1219693-73-8, 146479-72-3, 1359819-75-2; urofollitropin, 97048-13-0 | |
| 040 | |a Scopus |b spa |c AR-BaUEN |d AR-BaUEN | ||
| 030 | |a RBOEA | ||
| 100 | 1 | |a Wolfenson, C. | |
| 245 | 1 | 0 | |a Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| 260 | |b Reproductive Healthcare Ltd |c 2005 | ||
| 270 | 1 | 0 | |m Jespersen, S.; Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark; email: sonja.jespersen@ferring.com |
| 506 | |2 openaire |e Política editorial | ||
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| 504 | |a Gervais, A., Hammel, Y.-A., Pelloux, S., Glycosylation of human gonatrophins: Characterization and batch-to-batch consistency (2003) Glycobiology, 13, pp. 179-189 | ||
| 504 | |a Green, E., Baenziger, J., Asparagine-linked oligosaccharides on lutropin, follitropin, and thyrotropin. I. Structural elucidation of the sulfated and sialylated oligosaccharides on bovine, ovine, and human pituitary glycoprotein hormones (1988) Journal of Biological Chemistry, 263, pp. 25-35 | ||
| 504 | |a Green, E., Baenziger, J., Asparagine-linked oligosaccharides on lutropin, follitropin, and thyrotropin. II. Distributions of sulfated and sialylated oligosaccharides on bovine, ovine, and human pituitary glycoprotein hormones (1988) Journal of Biological Chemistry, 263, pp. 36-44 | ||
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| 504 | |a Mulders, J.W.M., Derksen, M., Swolfs, A., Prediction of the in vivo biological activity of human recombinant follicle stimulating hormone using quantitative isoelectric focusing (1997) Biologicals, 25, pp. 269-281 | ||
| 504 | |a Recombinant follicle stimulating hormone: Development of the first biotechnology product for the treatment of infertility (1998) Human Reproduction Update, 4, pp. 862-881. , Recombinant Human FSH Product Development Group | ||
| 504 | |a Richards, J., Estradiol receptor content in rat granulosa cells during follicular development: Modification by estradiol and gonadotropins (1975) Endocrinology, 97, pp. 1174-1184 | ||
| 504 | |a Rose, M.P., Das, R.E.G., Balen, A.H., Definition and measurement of follicle stimulating hormone (2000) Endocrine Reviews, 21, pp. 5-22 | ||
| 504 | |a Sairam, M.R., Jiang, L.G., Yarney, T.A., Alternative splicing converts the G-protein coupled follitropin receptor gene into a growth factor type I receptor: Implications for pleiotropic actions of the hormone (1997) Molecular Reproduction and Development, 48, pp. 471-479 | ||
| 504 | |a Sasano, H., Okamoto, M., Mason, J., Immunolocalization of aromatase, 17 alpha-hydroxylase and side-chain-cleavage cytochromes P-450 in the human ovary (1989) Journal of Reproduction and Fertility, 85, pp. 163-169 | ||
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| 504 | |a Timossi, C., Dámian-Matsumura, P., Dominguez-González, R., A less acidic human follicle-stimulating hormone preparation induce tissue-type plasminogen activator enzyme activity earlier than a predominantly acidic analogue in phenobarbital-blocked pro-oestrous rats (1998) Molecular Human Reproduction, 4, pp. 1032-1038 | ||
| 504 | |a Timossi, C.M., Tomasib, J.B.D., Zambranob, E., A naturally occurring basically charged human follicle-stimulating hormone (FSH) variant inhibits FSH-induced androgen aromatization and tissue-type plasminogen activator enzyme activity in vitro (1998) Neuroendocrinology, 67, pp. 153-163 | ||
| 504 | |a Timossi, C.M., Barrios-de-Timossi, J., González-Suárez, R., Differential effect of the charge variants of human follicle-stimulating hormone (2000) Journal of Endocrinology, 165, pp. 193-205 | ||
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| 504 | |a Westergaard, L.G., Erb, K., Laursen, S.B., Human menopausal gonadotropin versus recombinant follicle-stimulating hormone in normogonadotropic women down-regulated with a gonadotropin-releasing hormone agonist who were undergoing in vitro fertilization and intracytoplasmic sperm injection: A prospective randomized study (2001) Fertility and Sterility, 76, pp. 543-549 | ||
| 504 | |a Wide, L., The regulation of metabolic clearance rate of human FSH in mice by variation of the molecular structure of the hormone (1986) Acta Endocrinologica, 112, pp. 336-344 | ||
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| 520 | 3 | |a Different gonadotrophin preparations derived from human urine or manufactured by recombinant technology are currently used in clinical practice for the treatment of infertility. It has been widely assumed that gonadotrophin products manufactured by recombinant technology have better batch-to-batch consistency compared with human-derived preparations and that this potentially will be shown to provide a more constant clinical response, but there is little evidence for either statement. This study compared the batch-to-batch consistency between urinary-derived and recombinant manufactured gonadotrophin preparations using standard analytical techniques, as well as a novel in-vitro follicle bioassay to evaluate the consistency of the biological response at the target organ. Oligosaccharide isoform profiling, immunoassay testing, size exclusion chromatography analysis and in-vitro bioassay testing of urinary derived gonadotrophin preparations (MENOPUR® and BRAVELLE®) confirm that these products display a high degree of batch-to-batch consistency, similar to recombinant FSH (GONAL-f®) either filled by mass or bioassay. The data also suggest that the batch-to-batch variation is independent of the manufacturing procedure (filled-by-bioassay of filled-by-mass) for the recombinant preparation (Gonal-f), but that the total FSH bioactivity delivered from a single dose preparation after reconstitution differs between the two manufacturing procedures. |l eng | |
| 593 | |a Instituto Massone S.A. Arias 4431, 1430 Buenos Aires, Argentina | ||
| 593 | |a CIHIDECAR, Faculty of Exact and Natural Science, University of Buenos Aires, Buenos Aires, Argentina | ||
| 593 | |a Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark | ||
| 593 | |a EggCentris NV, Kranenberg 6, 1731 Brussels, Belgium | ||
| 690 | 1 | 0 | |a BATCH-TO-BATCH CONSISTENCY |
| 690 | 1 | 0 | |a GONADOTROPHIN |
| 690 | 1 | 0 | |a HUMAN-DERIVED |
| 690 | 1 | 0 | |a IN-VITRO FOLLICLE BIOASSAY |
| 690 | 1 | 0 | |a RECOMBINANT FSH |
| 690 | 1 | 0 | |a CHORIONIC GONADOTROPIN |
| 690 | 1 | 0 | |a HUMAN MENOPAUSAL GONADOTROPIN |
| 690 | 1 | 0 | |a ISOPROTEIN |
| 690 | 1 | 0 | |a OLIGOSACCHARIDE |
| 690 | 1 | 0 | |a RECOMBINANT FOLLITROPIN |
| 690 | 1 | 0 | |a UROFOLLITROPIN |
| 690 | 1 | 0 | |a ANALYTIC METHOD |
| 690 | 1 | 0 | |a ARTICLE |
| 690 | 1 | 0 | |a CLINICAL PRACTICE |
| 690 | 1 | 0 | |a DRUG DESIGN |
| 690 | 1 | 0 | |a DRUG DETERMINATION |
| 690 | 1 | 0 | |a DRUG DOSAGE FORM |
| 690 | 1 | 0 | |a DRUG MANUFACTURE |
| 690 | 1 | 0 | |a DRUG POTENTIATION |
| 690 | 1 | 0 | |a DRUG QUALITY |
| 690 | 1 | 0 | |a EVIDENCE BASED MEDICINE |
| 690 | 1 | 0 | |a HUMAN |
| 690 | 1 | 0 | |a IMMUNOASSAY |
| 690 | 1 | 0 | |a IN VITRO STUDY |
| 690 | 1 | 0 | |a INFERTILITY |
| 690 | 1 | 0 | |a OVARY FOLLICLE MATURATION |
| 690 | 1 | 0 | |a TARGET ORGAN |
| 690 | 1 | 0 | |a URINE |
| 653 | 0 | 0 | |a bravelle, Ferring, United Kingdom; gonal f; humegon, Organon, Netherlands Antilles; menopur, Ferring, United Kingdom; pergonal, Serono, Switzerland |
| 700 | 1 | |a Groisman, J. | |
| 700 | 1 | |a Couto, A.S. | |
| 700 | 1 | |a Hedenfalk, M. | |
| 700 | 1 | |a Cortvrindt, R.G. | |
| 700 | 1 | |a Smitz, J.E.J. | |
| 700 | 1 | |a Jespersen, S. | |
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