Gonadotrophins – filled-by-mass versus filled-by-bioassay

Application of recombinant technology to FSH in the early 1990s produced a highly purified preparation. Calibration of the product was dependent on the rat ‘bioassay’ based on measurement of ovarian weight after injection of FSH into rats. This test is associated with variability in the measurement...

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Bibliographic Details
Published in:Reproductive biomedicine online 2005-06, Vol.10, p.11-17
Main Authors: Hugues, Jean-Noel, Durnerin, I Cédrin
Format: Article
Language:English
Subjects:
Biological Assay
Calibration
Chemistry, Pharmaceutical
Fertilization in Vitro
filled-by-mass process
Follicle Stimulating Hormone - analysis
Follicle Stimulating Hormone - therapeutic use
Humans
IVF
ovulation induction
recombinant FSH
Recombinant Proteins - analysis
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Summary:Application of recombinant technology to FSH in the early 1990s produced a highly purified preparation. Calibration of the product was dependent on the rat ‘bioassay’ based on measurement of ovarian weight after injection of FSH into rats. This test is associated with variability in the measurement of FSH bioactivity (10–20%) and in the batch-to-batch FSH content. To improve calibration of the final product, a new concept of measuring the final product by mass was developed for follitropin alfa, which has a very consistent isoform profile and a high specific activity. The new formulation of follitropin alfa (FbM) displays a very low batch-to-batch variability (
ISSN:1472-6483
1472-6491
DOI:10.1016/S1472-6483(11)60385-4