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本文围绕重组糖蛋白激素的生物效价定义与来源,从糖基化修饰与生物活性之间重要关系为切入点,阐释建立糖基化分析方法和判断指标(如Z值)对于该类产品质量控制的重要性和可行性,对糖基化的一致性、糖谱(Z值)、蛋白含量等理化指标与生物效价的密切关系进行回顾解析,为今后此类生物类似药的研发评价提出意见和建议。
This article focuses on the definition and source of bio-potency of recombinant glycoprotein hormones, starting from the important relationship between glycosylation modification and bioactivity as an entry point, and explains the establishment of glycosylation analysis methods and indicators (such as Z value) for the quality of such products The importance and feasibility of control, the consistency of glycosylation, the glycosylation (Z value), protein content and other physical and chemical indicators and the biological potency of the close relationship to review and analysis for the future evaluation of such biological analogues R & D Opinions and suggestions.