WHO/BS/2019.2356 WHO 1st IS for Darbepoetin, for bioassay

Overview

Herein we report the production and evaluation of a candidate International Standard for darbepoetin, for the calibration of in vitro bioassays. A preparation of darbepoetin was formulated, dispensed into ampoules and lyophilized at the National Institute for Biological Standards and Control (NIBSC, UK).

The suitability of this preparation to serve as an International Standard was then evaluated in a collaborative study, in which ten participating laboratories performed in vitro bioassays. The results of the study suggest that the candidate preparation is suitable to serve as an International Standard for darbepoetin. Therefore, it is proposed that the candidate preparation, coded 17/204, is established as the 1^st WHO IS for darbepoetin, for bioassay with an assigned content of 100,000 IU per ampoule.

This International Standard is intended to support in vitro bioassay calibration and validation by defining the International Unit (IU) of bioactivity. The proposed unitage is not intended to revise product labelling or dosing requirements. Furthermore, the International Standard is not intended to define the specific activity of darbepoetin products, nor to serve any regulatory role in defining biosimilarity.