Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CE‐SDS method for vaccine protein analysis based on a commercially available gel buffer. The CMPs were obtained from reviewing the literature and testing the effects of gel buffer dilution. A four‐step approach, including two multivariate DoE (design of experiments) steps, was proposed, based on CMPs and was verified by CE‐SDS method development for: (i) the determination of influenza group 1 mini‐hemagglutinin glycoprotein; and (ii) the determination of polio virus particle proteins from an inactivated polio vaccine (IPV). The CMPs for sample preparation were incubation temperature(s) and time(s), pH, and reagent(s) concentration(s), and the detection wavelength. The effects of gel buffer dilution revealed the CMPs for CE‐SDS separation to be the effective length, the gel buffer concentration, and the capillary temperature. The four‐step approach based on the CMPs was efficient for the development of the two CE methods. A four‐step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis was successfully established.

中文翻译：

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高效开发用于病毒疫苗蛋白分析的毛细管凝胶电泳方法的四步方法。

迫切需要针对传染病的疫苗。因此，现代分析方法的开发应尽可能高效，以加快疫苗开发。该研究的目的是确定关键方法参数 (CMP) 并建立一套步骤，以有效开发和验证基于市售凝胶缓冲液的疫苗蛋白分析 CE-SDS 方法。CMP 是通过查阅文献和测试凝胶缓冲液稀释的效果获得的。提出了一种四步方法，包括两个多变量 DoE（实验设计）步骤，基于 CMP，并通过 CE-SDS 方法开发验证：（i）测定流感组 1 微型血凝素糖蛋白；(ii) 从灭活脊髓灰质炎疫苗 (IPV) 中测定脊髓灰质炎病毒颗粒蛋白。用于样品制备的 CMP 是孵育温度和时间、pH 和试剂浓度以及检测波长。凝胶缓冲液稀释的影响揭示了用于 CE-SDS 分离的 CMPs 是有效长度、凝胶缓冲液浓度和毛细管温度。基于 CMP 的四步方法对于开发两种 CE 方法是有效的。成功建立了一种高效开发用于病毒疫苗蛋白分析的毛细管凝胶电泳方法的四步方法。基于 CMP 的四步方法对于开发两种 CE 方法是有效的。成功建立了一种高效开发用于病毒疫苗蛋白分析的毛细管凝胶电泳方法的四步方法。基于 CMP 的四步方法对于开发两种 CE 方法是有效的。成功建立了一种高效开发用于病毒疫苗蛋白分析的毛细管凝胶电泳方法的四步方法。