NIBSC生物制品标准物质管理状况分析

Introduction of NIBSC international biological reference standards

关键词:  NIBSC  生物制品标准物质  制备  管理

Key words:  NIBSC  biological reference standards  preparation  management

摘要:

NIBSC是目前世界上WHO 国际生物制品标准物质的主要制备人和分发人,95% 以上的标准由其提供。疫苗、治疗中的大多数生物技术产品以及其它许多生物产品的有效使用都取决于 NIBSC 所提供的国际生物学标准的可用性。随着我国兽用生物制品事业的迅猛发展和生物制品质量要求的不断提高,对兽用生物制品标准物质的需求量也日益增加。本文就NIBSC生物制品标准物质的情况作一概述,并提出一些关于我国兽用生物制品标准物质的想法与建议。

Abstract:

NIBSC is the leading WHO International Laboratory for Standards. The Institute is currently the world’s major producer and distributor of WHO International Standards and reference materials (supplying over 95% of Standards). The effective use of vaccines, most biotechnology products in therapy and many other biologicals depends on the availability of international biological standards supplied by NIBSC. With the rapid development and the quality requirements of veterinary biological products in our country, the demand for veterinary biological reference standards is increasing. The paper reviews the situation of NIBSC biological reference standards, and puts forward some suggestions on veterinary biological reference standards of our country.