Hayakawa T
Eisei Shikenjo Hokoku. 1994(112):202-3.
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.
包括生物技术在内的蛋白质药物生产技术以及蛋白质表征方法学方面的最新进展，使我们能够大规模生产并广泛表征高纯度蛋白质药物。基于这样的背景，这些蛋白质药物的质量控制应使用各种现代蛋白质分析方法来进行。关于这些蛋白质药物的控制策略，需要考虑的要点之一是开发和标准化更特异、精确、简单且经济的检测方法。用某些体外检测方法（包括物理化学检测方法）替代现有的体内生物检测方法，是朝着这个方向的一个可能途径。本文描述了用物理化学检测方法替代蛋白质药物体内生物检测方法的策略。此类方法已应用于重组人生长激素和重组人胰岛素，其效价此前通过体内生物检测进行评估。本文还讨论了此类方法的科学依据。
