NIBSC 战略目标:对有关生物产品的问题给出回复和建议;提供生物药品方面的国家科技力量,维持满足科学和药物学领域新发展需求的灵活性、专业知识和设施;作为化验方法(如量化生物学活性以及确定生物产品特征和进行安全评估)方面的国际领先权威机构运营并得到认同;在欧洲生物产品的控制和标准化方面,继续发挥科学基础开发的中心作用;在生物药品法规的科学方面帮助国际社会达成共识,并籍于此,与世界卫生组织紧密合作;在控制和标准化的关键领域实现和维护质量鉴定,如药品中使用的生物物质包括病毒和细菌疫苗、从人类血液提取的产物、荷尔蒙以及其它诸如细胞分裂素和生长素等治疗药物。
这些生物物质对药物学和公众健康做出了巨大贡献并发挥着越来越大的作用,它们大大改善了全世界的疾病预防、诊断和治疗。
生物药品是非常复杂的产品,正因为如此,大多数生物药品在投入使用前都会经过独立测试。在英国和欧盟,生物产品在投入使用前会先提交到欧盟的其中一个 OMCL进行测试。确保疫苗的安全性尤其重要,因为它们将在全国范围内的免疫活动中用于大量健康的个人。
通过研究院的测试和评估工作,NIBSC的科学家们帮助确保了生物产品的安全和有效性,同时也帮助缩短了将新产品投入临床使用的时间。新产品,如最新一代复合疫苗,需要采取新颖的方法加以控制。作为基因革命带来的影响之一,生物产品在数量和复杂程度上的潜在大幅增长也需要有更为彻底的控制战略方案。
提供标准用于确保生物产品潜能的复杂化验要求使用生物学活性标准(有一批物质被指定了活性单位并用作“基准”)。 世界卫生组织 (WHO) 国际标准系统提供了一组常用标准,它使得世界各地的质量测试结果具有可比性,也因此而重要非凡。国际标准是“金标准”,各国以及各生产商都可据此制定出自己的生物学测试标准。
NIBSC 是目前世界上 WHO 国际标准和参考材料的主要制作人和分发人(提供 95% 以上的标准)。对疫苗、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。
NIBSC strategic objectives: to respond to and advise on questions related to biological products; To provide national scientific and technological capabilities in biologics and to maintain the flexibility, expertise and facilities to meet the needs of new developments in science and pharmacology; Operates and is recognized as a leading international authority on assay methods such as quantifying biological activity and identifying and conducting safety assessments of biological products; Continue to play a central role in science-based development in the control and standardization of biological products in Europe; Working closely with the World Health Organization to help build international consensus on the scientific aspects of biologics regulation; Achieve and maintain quality identification in key areas of control and standardization, such as biological substances used in pharmaceutical products including viral and bacterial vaccines, products derived from human blood, hormones and other therapeutic agents such as cytokinins and auxin.
These biological substances have greatly contributed to and are playing an increasing role in medicine and public health, greatly improving disease prevention, diagnosis and treatment worldwide.
Biologics are very complex products, which is why most biologics undergo independent testing before they are put into use. In the UK and the EU, biological products are submitted to one of the EU's OMCL for testing before they are put into use. Ensuring the safety of vaccines is particularly important as they will be used on a large number of healthy individuals in nationwide immunization campaigns.
Through the institute's testing and evaluation work, NIBSC scientists help ensure the safety and effectiveness of biological products, while also helping to reduce the time it takes to bring new products to clinical use. New products, such as the latest generation of combination vaccines, need to be controlled in novel ways. The potential for a dramatic increase in the number and complexity of biological products, one of the effects of the genetic revolution, also requires more thorough control strategies.
Complex assays that provide criteria to ensure the potential of biological products require the use of biological activity criteria (a group of substances are designated as active units and used as "benchmarks"). The World Health Organization (WHO) International Standards System provides a common set of standards that are important for making quality test results comparable around the world. International standards are the "gold standard" from which countries and manufacturers can develop their own biological testing standards.
NIBSC is currently the world's leading producer and distributor of international standards and reference materials for WHO (providing more than 95% of standards). The effective use of vaccines, most biotechnology products in therapeutics, and many other biological products depends on the availability of international biological standards provided by the NIBSC.