56th report: WHO TRS N°941: 2005

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 24 to 28 October 2005. The meeting was opened by Dr J.M. Okwobele, Director, Department of Immunization, Vaccines and Biologicals on behalf of the Director-General.

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, and endocrinological substances. The second part of the report, of particular relvance to manufacturers and national regulatory authorities, contains guidelines on quality, safety and efficacy of live attenuated rotavirus vaccines; DNA vaccines; a biosafety risk assessment for production and quality control of human influenza pandemic vaccines; recommendations for inactivated rabies vaccines produced in cell substrates and embryonated eggs; for whole cell pertussis vaccine; and for production, control and regulation of human plasma for fractionation. Also included are a list of recommendations, guidelines, and other documents for biological susbtances used in medicine, and of international standards and reference reagent for biological susbtances.