60th report: WHO TRS N°977: 2009

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 19 to 23 October 2009. The meeting was opened on behalf of the DirectorGeneral by Ms Daisy Mafubelu, Assistant Director-General of the Family and Community Health cluster. She invited the members and the observers to introduce themselves.

The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO Recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO Guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided.

Also included are a list of Recommendations, Guidelines and other documents for biological substances used in medicine, and of International Standards and Reference Reagent for biological substances.