Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations¹

METHODS

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.

RESULTS

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.

CONCLUSION

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.

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