WHO/BS/2014.2236 Collaborative Study for the Establishment of the 2nd IS for Bleomycin complex A2/B2

Overview

This report describes the results and the outcome of an international collaborative study organised to establish the second World Health Organization (WHO) International Standard (IS) for Bleomycin complex A2/B2. 8 laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the first IS for Bleomycin complex A2/B2 was used as reference.

This report provides details about the material donated by a manufacturer, the processing involved to generate a candidate batch and the analytical controls to assess its quality. It includes statistical analysis of the results, the conclusions made thereof and a recommendation to the WHO Expert Committee for Biological Standardization (ECBS).

It is proposed that the second WHO International Standard for Bleomycin complex A2/B2 (EDQM internal code ISA_46290) be assigned an antimicrobiological activity of 12 500 IU/vial.