Renewing potency assays: Moving forward from traditional methods

Authors

  • Francesco Nevelli Merck Biopharma, Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A., Colleretto Giacosa (Turin)

DOI:

https://doi.org/10.4081/bse.97

Keywords:

Potency assay, quality control, in vitro, growth Hormone, GMP

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.

Downloads

Download data is not yet available.

References

Downloads

Published

12-02-2020

Issue

Vol. 1 No. 1 (2020)

Section

Original Articles

License

Copyright (c) 2019 The Authors

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.

How to Cite

Renewing potency assays: Moving forward from traditional methods. (2020). Biomedical Science and Engineering, 1(1). https://doi.org/10.4081/bse.97