World Health Organ Tech Rep Ser. 2007(941):1-340, back cover.
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 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 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，以促成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，并提供了各类抗体、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情况。报告第二部分对制造商和国家监管当局尤为重要，其中包含减毒活轮状病毒疫苗、DNA疫苗的质量、安全性和有效性指南；人流感大流行疫苗生产和质量控制的生物安全风险评估；细胞基质和鸡胚生产的灭活狂犬病疫苗的建议；全细胞百日咳疫苗的建议；以及人血浆成分分离的生产、控制和监管建议。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。
