PDF(Pubmed)
Abstract：
Aim: An assay to detect anti-tocilizumab antibodies in the presence of high levels of circulating target and drug is needed for immunogenicity assessment in comparative clinical studies.Methods: An assay was developed and validated using a combination of blocking agents and dilutions to overcome target interference challenges.Results: No false-positive signal was detected in serum samples spiked with 350-500 ng/ml of IL-6 receptor. As low as 50 ng/ml of positive control antibodies could be detected in the presence of either 500 ng/ml of IL-6 or 250 μg/ml of the drug product. Assay also demonstrated high sensitivity, selectivity and precision.Conclusion: A robust, easy to perform immunogenicity assay was developed and validated for detecting anti-tocilizumab antibodies.
[Box: see text].
[Box: see text].
摘要：
目的：在比较临床研究中，需要在高水平的循环靶标和药物存在下检测抗托珠单抗抗体的测定法，以进行免疫原性评估。方法:使用阻断剂和稀释液的组合开发和验证测定法以克服靶标干扰挑战。结果:在掺入350-500ng/mlIL-6受体的血清样品中未检测到假阳性信号。在500ng/mlIL-6或250yg/ml药物产品的存在下,可以检测到低至50ng/ml的阳性对照抗体。测定还显示出高灵敏度，选择性和精密度。结论：一个强大的，开发了易于进行的免疫原性测定,并验证了用于检测抗托珠单抗抗体.
[方框：见正文]。
[方框：见正文]。
