NIBSC

2020/04/28 15
  • 品牌国家:英国
  • 代理区域:中国
  • 代理授权证书:

英国国家生物制品检定所(National Institute for Biological Standards and Control,NIBSC),英国国家生物制品及标准化控制研究所,是英国药品及卫生保健产品管理机构的枢纽与执行机构,英国生物医药检验实验室,主要的WHO国际生物制品标准实验室及WHO负责脊髓灰质炎、流感及HIV研究的协作中心,英国干细胞库,同时也是生物药制剂鉴定及其标准对照品生产供应的全球。NIBSC处于一个位于产品制造、调节、政策制定及学术前沿的独特国际位置,通过提供生物制剂标准参照品、生物制剂鉴定及相关研究确保全球生物医药制品的质量,同时也为生物医药产品的研发提供有力支持。

NIBSC提供生物医学研究领域大量的国际标准、参照品及试剂,包括WHO国际标准、流感试剂、质控试剂及其他欧盟认证的体外诊断试剂。在NIBSC的在线目录中,可以采购到所有生物制品参照材料、流感试剂及体外诊断产品。此外,NIBSC还供应AIDS试剂中心提供的超过6000种研究试剂,资源中心供应的Creutzfeldt-Jakob病评估、诊断及研究试剂。在细胞生物学研究领域,NIBSC还提供包括人类胚胎干细胞及其他干细胞等多种细胞株,用于科学研究及疾病疫苗测试

NIBSC提供对投入英国市场的生物药品的独立测试,尤其是用于英国儿童免疫计划的疫苗;它同时也是欧盟控制药品进入欧盟市场的官方药品控制实验室(OMCL)。 

We are the leading WHO Collaborating Centre and International Laboratory for Biological Standards, Essential Regulatory Laboratory (ERL) for Influenza, WHO Collaborating Centre for Reference & Research on Poliomyelitis and the WHO Global Specialised Polio Network Laboratory.

We occupy a unique international position as the interface between:

  • product manufacturers

  • regulators

  • policy makers

  • cutting-edge academic research


The Institute is the UK’s Official Medicines Control Laboratory (OMCL), responsible for carrying out independent official batch release testing of biological medicines as required by EU law. 

Biological medicines and vaccines are usually very complex materials. In order to ensure that these products are both safe and effective it is necessary to thoroughly evaluate their quality and biological activity. Each batch is examined and approved, independently from the manufacturers, and issued with a EU/EEA OCABR certificate before being released onto the market.

Biological substances used in healthcare include bacterial and viral vaccines against diseases such as: 

  • diphtheria

  • whooping-cough

  • meningitis

  • poliomyelitis

  • influenza

  • hepatitis

  • measles

  • mumps

  • rubella 

They also include therapeutic products derived from human blood such as clotting factors and immunoglobulins, as well as other products such as monoclonal antibodies, hormones, cytokines and growth factors. 




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