World Health Organ Tech Rep Ser. 2006;932:v-vi, 1-137.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. 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 relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterization and establishment of international and other biological reference standards. 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.
本报告介绍了世界卫生组织一个专家委员会的建议，该委员会受委托协调各项活动，以推动通过关于疫苗及其他生物制品生产与控制的国际建议，并建立国际生物参考物质。报告开篇讨论了引起委员会关注的一般性问题，并提供了各种抗体、抗原、血液制品及相关物质、细胞因子、生长因子和内分泌物质参考物质的现状与发展信息。报告的第二部分对制造商和国家监管当局尤为重要，其中包含候选四价登革病毒疫苗生产和质量控制指南，以及关于国际和其他生物参考标准的制备、特性鉴定和建立的建议。此外，还列出了用于医学的生物物质的建议、指南和其他文件清单，以及生物物质的国际标准和参考试剂清单。
