65th report: : 2014

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 13 to 17 October 2014. The meeting was opened by Mr Kees de Joncheere, Director of the Department of Essential Medicines and Health Products (EMP). Mr de Joncheere welcomed the Committee, meeting participants and observers, and reminded the Committee that it has a mandate to review developments in the field of biological substances that include vaccines, biological therapeutics, blood products and related in vitro diagnostic devices. The proactive technical support provided by WHO, together with WHO collaborating centres (WHOCCs) and partner organizations, remains key to facilitating the consistent application of standards.

Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee. Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances.