Equivalent Recombinant Human Insulin Preparations and their Place in Therapy.
Equivalent Recombinant Human Insulin Preparations and their Place in Therapy.
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DOI：
10.17925/ee.2015.11.01.10
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发表时间：
2015-04-01
影响因子：
--
通讯作者：
Seipke, Gerhard
中科院分区：
文献类型：
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作者：
Sandow, Juergen;Landgraf, Wolfgang;Seipke, Gerhard
重组人胰岛素是生物技术的首批产品之一。它的开发是为了满足全球范围内持续和充足供应的需求。重组人胰岛素取代了动物胰岛素和通过动物胰岛素修饰得到的半合成胰岛素。监管部门批准需要进行生物等效性研究。在这些过程中独立建立了三种参考产品：优泌林（Eli Lilly and Co）、诺和灵（NovoNordisk）和Insuman（赛诺菲）。在重组人胰岛素制剂的商业开发过程中使用了许多品牌名称。在本次审查中，使用了三个当前的品牌名称来进行一致的识别。人胰岛素优泌林和胰岛素是在细菌（大肠杆菌）中发酵产生的，而诺和灵则在酵母（酿酒酵母）中发酵产生的。在正常血糖钳夹研究中研究了重组人胰岛素产品的生物等效性。这里提供了此类生物等效性研究的概述。本文将考虑当今人胰岛素制剂的相关性及其在治疗中的地位。
Recombinant human insulin was one of the first products of biotechnology. It was developed in response to the need for a consistent and sufficient worldwide supply. Recombinant human insulin replaced the animal insulins and semisynthetic insulins obtained by modification of animal insulins. Bioequivalence studies were required for regulatory approval. Three reference products were independently established during these procedures: Humulin (Eli Lilly and Co), Novolin (NovoNordisk) and Insuman (Sanofi). Numerous brand names have been used during the commercial development of recombinant human insulin formulations. In this review, three current brand names are used for consistent identification. Human insulin for Humulin and Insuman are produced by fermentation in bacteria (Escherichia coli) and for Novolin in yeast (Saccharomyces cerevisiae). The bioequivalence of recombinant human insulin products was investigated in euglycaemic clamp studies. An overview of such bioequivalence studies is provided here. This paper will consider the relevance of human insulin formulations today and their place in therapy.