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...
Guardado en:
| Autores principales: | , , , , , , |
|---|---|
| Formato: | JOUR |
| Materias: | |
| Acceso en línea: | http://hdl.handle.net/20.500.12110/paper_14726483_v10_n4_p442_Wolfenson |
| Aporte de: |
| id |
todo:paper_14726483_v10_n4_p442_Wolfenson |
|---|---|
| record_format |
dspace |
| spelling |
todo:paper_14726483_v10_n4_p442_Wolfenson2023-10-03T16:17:56Z Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations Wolfenson, C. Groisman, J. Couto, A.S. Hedenfalk, M. Cortvrindt, R.G. Smitz, J.E.J. Jespersen, S. Batch-to-batch consistency Gonadotrophin Human-derived In-vitro follicle bioassay Recombinant FSH chorionic gonadotropin human menopausal gonadotropin isoprotein oligosaccharide recombinant follitropin urofollitropin analytic method article clinical practice drug design drug determination drug dosage form drug manufacture drug potentiation drug quality evidence based medicine human immunoassay in vitro study infertility ovary follicle maturation target organ urine 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. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_14726483_v10_n4_p442_Wolfenson |
| institution |
Universidad de Buenos Aires |
| institution_str |
I-28 |
| repository_str |
R-134 |
| collection |
Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) |
| topic |
Batch-to-batch consistency Gonadotrophin Human-derived In-vitro follicle bioassay Recombinant FSH chorionic gonadotropin human menopausal gonadotropin isoprotein oligosaccharide recombinant follitropin urofollitropin analytic method article clinical practice drug design drug determination drug dosage form drug manufacture drug potentiation drug quality evidence based medicine human immunoassay in vitro study infertility ovary follicle maturation target organ urine |
| spellingShingle |
Batch-to-batch consistency Gonadotrophin Human-derived In-vitro follicle bioassay Recombinant FSH chorionic gonadotropin human menopausal gonadotropin isoprotein oligosaccharide recombinant follitropin urofollitropin analytic method article clinical practice drug design drug determination drug dosage form drug manufacture drug potentiation drug quality evidence based medicine human immunoassay in vitro study infertility ovary follicle maturation target organ urine Wolfenson, C. Groisman, J. Couto, A.S. Hedenfalk, M. Cortvrindt, R.G. Smitz, J.E.J. Jespersen, S. Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| topic_facet |
Batch-to-batch consistency Gonadotrophin Human-derived In-vitro follicle bioassay Recombinant FSH chorionic gonadotropin human menopausal gonadotropin isoprotein oligosaccharide recombinant follitropin urofollitropin analytic method article clinical practice drug design drug determination drug dosage form drug manufacture drug potentiation drug quality evidence based medicine human immunoassay in vitro study infertility ovary follicle maturation target organ urine |
| description |
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. |
| format |
JOUR |
| author |
Wolfenson, C. Groisman, J. Couto, A.S. Hedenfalk, M. Cortvrindt, R.G. Smitz, J.E.J. Jespersen, S. |
| author_facet |
Wolfenson, C. Groisman, J. Couto, A.S. Hedenfalk, M. Cortvrindt, R.G. Smitz, J.E.J. Jespersen, S. |
| author_sort |
Wolfenson, C. |
| title |
Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| title_short |
Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| title_full |
Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| title_fullStr |
Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| title_full_unstemmed |
Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| title_sort |
batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations |
| url |
http://hdl.handle.net/20.500.12110/paper_14726483_v10_n4_p442_Wolfenson |
| work_keys_str_mv |
AT wolfensonc batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT groismanj batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT coutoas batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT hedenfalkm batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT cortvrindtrg batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT smitzjej batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations AT jespersens batchtobatchconsistencyofhumanderivedgonadotrophinpreparationscomparedwithrecombinantpreparations |
| _version_ |
1782030252002770944 |