Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Cornell University, Ithaca, New York, USA.
AAPS J. 2018 Apr 24;20(3):65. doi: 10.1208/s12248-018-0228-3.
PEGylation is a modification commonly used to increase the half-life of therapeutic proteins. The strategy for immunogenicity testing of these compounds should include methods to detect both anti-protein and anti-PEG antibodies. We previously reported a method for the detection of anti-PEG antibodies using ProterixBio's (formerly BioScale) acoustic membrane microparticle (AMMP) technology. Our initial method development work showed the assay was capable of detecting antibodies in human serum with a sensitivity of 1 μg/mL with good reproducibility (CV < 7%). Since the publication of this initial paper, additional experimentation was performed in an effort to validate the assay for support of clinical sample analysis. This additional data indicate that the method has high variability (CV% > 20) and is unsuitable to support clinical sample analysis.
聚乙二醇化是一种常用的修饰方法，用于增加治疗性蛋白的半衰期。这些化合物的免疫原性测试策略应包括检测抗蛋白和抗聚乙二醇抗体的方法。我们之前报道了一种使用 ProterixBio（前身为 BioScale）的声膜微颗粒（AMMP）技术检测抗聚乙二醇抗体的方法。我们最初的方法开发工作表明，该测定法能够以 1μg/ml 的灵敏度检测人血清中的抗体，具有良好的重现性（CV<7%）。自最初论文发表以来，进行了额外的实验，以验证该测定法支持临床样本分析的能力。这些额外的数据表明该方法具有较高的变异性（CV%>20%），不适合支持临床样本分析。
