https://doi.org/10.4081/bse.97
Renewing potency assays: Moving forward from traditional methods
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Merck is global market leader in the fertility and growth hormone deficiency treatment. The quality control analytical panels for each new produced batch envisage the potency quantification that is estimated using a dedicated in vivo assay. Indeed, no in vitro methods for gonadotropin potency quantification are available in any pharmacopoeia. Merck Ivrea started a project to replace the in vivo assays with in vitro assays able to mimic the physiological mechanism of action of each gonadotropin and growth hormone.
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