[Scientific rationale for the replacement of an in vivo bioassay for protein drugs with a physico-chemical assay].

T Hayakawa
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Abstract

Recent progress in both protein drug production technologies including biotechnology and protein characterization methodologies has enabled us to mass-produce and extensively characterize highly purified protein drugs. The quality control of these protein drugs, being based on such a background, should be carried out using various modern protein analytical methodologies. One of the points to be considered regarding control strategies for these protein drugs should be the development and standardization of more specific, precise, simple and economical assay methodology. The replacement of existing in vivo bioassays with certain in vitro assays, including physico-chemical assays, is one possible directions along this line. This paper describes strategies for the replacement of an in vivo bioassay for protein drugs with a physico-chemical assay. Such approaches have been applied for recombinant human growth hormone and recombinant human insulin, the potencies of which have been estimated by in vivo bioassay. Scientific rationale for such approaches are also discussed.

【用理化分析替代蛋白质药物体内生物测定的科学原理】。
蛋白质药物生产技术的最新进展,包括生物技术和蛋白质表征方法,使我们能够大规模生产和广泛表征高纯度的蛋白质药物。基于这样的背景,这些蛋白质药物的质量控制应采用各种现代蛋白质分析方法进行。关于这些蛋白质药物的控制策略,需要考虑的一点是开发和标准化更具体、精确、简单和经济的分析方法。用某些体外测定法(包括理化测定法)取代现有的体内生物测定法是沿着这条路线发展的一个可能方向。本文描述了用物理化学分析方法代替蛋白质药物体内生物测定的策略。这种方法已应用于重组人生长激素和重组人胰岛素,其效力已通过体内生物测定法估计。对这种方法的科学原理也进行了讨论。
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