This work is a systematic evaluation of the experimental parameters of the most widely used in vitro recombinant human bone morphogenetic protein-2 (rhBMP-2) activity assays. The variations in assays reported in the literature have challenged the reproducibility and translation of work using rhBMP-2 as a bone-inducing growth factor. By elucidating the effect of model cell line on the dose-dependent alkaline phosphatase response to rhBMP-2 induction and by establishing a correlation between protein activity and protein concentration by enzyme-linked immunosorbent assay using commercially available rhBMP-2, this work is a significant step toward developing an in vitro-in vivo correlation between quantified activity and clinical efficacy.

中文翻译：

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重组骨形态发生蛋白2生物活性对再生医学的体外评估。

这项工作是对最广泛使用的体外重组人骨形态发生蛋白2（rhBMP-2）活性测定的实验参数的系统评价。文献中报道的测定方法的变化已经挑战了使用rhBMP-2作为骨诱导生长因子的可重复性和工作翻译。通过阐明模型细胞系对rhBMP-2诱导的剂量依赖性碱性磷酸酶反应的影响，并通过使用市售rhBMP-2的酶联免疫吸附法确定蛋白质活性与蛋白质浓度之间的相关性，这项工作具有重要意义。在定量活性和临床疗效之间建立体内外相关性的步骤。