61st report: WHO TRS N°978: 2010

Overview

The World Health Organization (WHO) Expert Committee on Biological Standardization met in Geneva from 18 to 22 October 2010. The meeting was opened on behalf of the Director-General by Dr Jean-Marie Okwo-bele, Director, Immunization, Vaccines and Biologicals. Dr Okwo-bele emphasized that evidence-based international norms and standards for biological products, developed through rigorous, transparent, inclusive and authoritative processes, provided a solid foundation upon which health systems could build to deliver products of assured quality to address important public health problems. 

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 evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products, for production and control of hepatitis B vaccines and for production and control of yellow fever vaccines. New WHO Guidelines on the independent lot release of vaccines are also included. Finally, there is an update to the procedure for the prequalification of vaccines.

Also included are lists of Recommendations, Guidelines and other documents related to the manufacture and control of biological substances used in medicine, and of International Standards and Reference Reagents for biological substances.