WHO/BS/2017.2312 WHO International Collaborative Study of the Proposed 2nd IS for Parathyroid Hormone 1-34, Recombinant, Human

Overview

The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) has recognized the need for a replacement International Standard (IS) for parathyroid hormone 1-34, recombinant, human (rhPTH 1-34) in terms of which the content of therapeutic products can be expressed. We report here the calibration of a candidate standard for rhPTH 1-34 by HPLC assay in terms of a primary calibrant, by an international collaborative study carried out by twelve laboratories in eight countries. The mean of the laboratory estimates of the rhPTH 1-34 content of the candidate standard, coded 15/304, is 0.914 milligrams per ampoule (CV = 2.16%, n=28, expanded uncertainty of 0.902, 0.926 mg/amp) in terms of the primary calibrant. The study also included an assessment of the purity, bioactivity and stability of the candidate standard. The mean of the laboratory estimates of the rhPTH 1-34 purity of the candidate standard is 99.08% (CV = 0.59%, n=11). Bioassay data shows good agreement between the potencies of the candidate standard and the 1st WHO IS, 04/200. The results of this study also indicate that the candidate standard is sufficiently stable to serve as an IS.

Therefore, it is proposed that the candidate preparation in ampoules, coded 15/304, is established as the 2 nd WHO IS for parathyroid hormone 1-34, recombinant, human with an assigned content of 0.914 mg per ampoule.