Renewing potency assays: Moving forward from traditional methods

  • Francesco Nevelli | francesco.nevelli@merckgroup.com Merck Biopharma, Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A., Colleretto Giacosa (Turin), Italy.

Abstract

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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Published
2020-02-12
Keywords:
Potency assay, quality control, in vitro, growth Hormone, GMP
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How to Cite
Nevelli, F. (2020). Renewing potency assays: Moving forward from traditional methods. Biomedical Science and Engineering, 3(s2). https://doi.org/10.4081/bse.2019.97