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首页> 外文会议>Protein Engineering Summit. >Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, and Ranibizumab
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Ready-to-Use Potency Assays for Bevacizumab, Aflibercept, and Ranibizumab

机译：Bevacizumab，AfliBelcept和Ranibizumab的即用效力效力测定

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Cell-based bioassays often pose a hurdle during a rapidly moving biologies development program. High standards for assay accuracy, precision, reproducibility and robustness are additionally put to the test by the use of continuous culture cells that can add to variability and increase the cost and complexity of each assay. This is particularly challenging for anti-VEGF drugs, as the prevalent assay is the proliferation of primary human umbilical vein endothelial cells (HUVECs), which requires 72-96 hours to run, utilizes primary cells that are difficult to culture and introduces performance variability due to changes in donor, passage number, culture conditions and analyst. Here, we describe a PathHunter? bioassay that has been developed as a fit-for-purpose potency & stability assay for anti-VEGF drugs. The assay quantifies inhibition of VEGF-A-induced VEGFR2 receptor activation, by measuring an early event in the receptor activation cascade. With its shorter assay time (<24 hours), simple ‘add and read’ protocol and use of cryopreserved ready-to-assay cells, the PathHunter assay has many advantages over the standard HUVEC assay. Qualification data will be presented on the performance of the PathHunter bioassay for bevacizumab, aflibercept and ranibizumab.
机译：基于细胞的生物测定通常在快速移动的生物学开发计划期间占据障碍。用于测定精度的高标准，精确度，再现性和鲁棒性另外通过使用连续培养细胞来进行测试，该细胞可以增加变异性并增加每个测定的成本和复杂性。这对于抗VEGF药物来说特别具有挑战性，因为普遍的测定是初级人脐静脉内皮细胞（HUVEC）的增殖，需要72-96小时来运行，利用难以培养的原代细胞，并引入绩效变化捐赠者，通道数，文化条件和分析师的变化。在这里，我们描述了一个路径？已经开发为抗VEGF药物的适当效力和稳定性测定的生物测定。该测定通过测量受体激活级联的早期事件来量化VEGF-A-诱导的VEGFR2受体活化的抑制。随着其较短的测定时间（<24小时），简单的“添加和读取”协议和使用冷冻保存的即食细胞，PathWunter测定与标准Huvec测定相比具有许多优点。资格数据将提出贝伐单抗，AfliBelcept和Ranibizumab的PathHunter Bioassay的表现。

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