BALANCING SCIENCE AND DREAMS
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A study compared the batch-to-batch consistency of recombinant versus urinary-derived preparations
Wolfenson C. et al. Reprod Biomed Online 2005;10:442–454
Study type: Biochemical analysis and in vitro bioassays.
Analytical techniques: Oligosaccharide isoform profiling, immunoassay testing, size exclusion chromatography analysis and in vitro follicle bioassays.
Comparator agents: Menopur®, GONAL-f® (recombinant follicle-stimulating hormone (rFSH)) and other urinary-derived gonadotrophins.
Oligosaccharide isoform profiling: Approximately 90% of the oligosaccharides in Menopur® are di- or tri-sialylated. The difference between minimum and maximum is less than 10% between batches of Menopur® and Bravelle® (FSH-HP).
Immunoassay testing: The intra-product variation (10.5%) of immunological hCG content in Menopur®, is of the same order of magnitude as the variation observed for FSH immunoactivity in Menopur®, GONAL-f® and other urinary derived gonadotrophins.
Size exclusion chromatography: The total intra-product variation seen by size exclusion chromatography is in line with that obtained by FSH immunoassay.
In vitro follicle bioassay: For all product batches, comparison of the three steroid concentration profiles by ANOVA demonstrated batch-to-batch consistency.
Oligosaccharide isoform profiling, immunoassay testing, size exclusion chromatography analysis and in-vitro bioassay testing confirmed that Menopur® displayed a high degree of batch-to-batch consistency, similar to GONAL-f® either filled by mass or bioassay.
Job Code: UK-MR-2300036 - Date of preparation: September 2023