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首页> 外文期刊>Vaccine >Simultaneous quantification of the viral antigens hemagglutinin and neuraminidase in influenza vaccines by LC-MSE
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Simultaneous quantification of the viral antigens hemagglutinin and neuraminidase in influenza vaccines by LC-MSE

机译：通过LC-MSE同时定量流感疫苗中的病毒抗原血凝素和神经氨酸酶

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摘要

Current methods for quality control of inactivated influenza vaccines prior to regulatory approval include determining the hemagglutinin (HA) content by single radial immunodiffusion (SRID), verifying neuraminidase (NA) enzymatic activity, and demonstrating that the levels of the contaminant protein ovalbumin are below a set threshold of 1 mu g/dose. The SRID assays require the availability of strain-specific reference HA antigens and antibodies, the production of which is a potential rate-limiting step in vaccine development and release, particularly during a pandemic. Immune responses induced by neuraminidase also contribute to protection from infection; however, the amounts of NA antigen in influenza vaccines are currently not quantified or standardized. Here, we report a method for vaccine analysis that yields simultaneous quantification of HA and NA levels much more rapidly than conventional HA quantification techniques, while providing additional valuable information on the total protein content. Enzymatically digested vaccine proteins were analyzed by LC-MSE, a mass spectrometric technology that allows absolute quantification of analytes, including the HA and NA antigens, other structural influenza proteins and chicken egg proteins associated with the manufacturing process. This method has potential application for increasing the accuracy of reference antigen standards and for validating label claims for HA content in formulated vaccines. It can also be used to monitor NA and chicken egg protein content in order to monitor manufacturing consistency. While this is a useful methodology with potential for broad application, we also discuss herein some of the inherent limitations of this approach and the care and caution that must be taken in its use as a tool for absolute protein quantification. The variations in HA. NA and chicken egg protein concentrations in the vaccines analyzed in this study are indicative of the challenges associated with the current manufacturing and quality control testing procedures
机译：在获得监管部门批准之前，目前用于灭活流感疫苗质量控制的方法包括通过单次径向免疫扩散（SRID）确定血凝素（HA）含量，验证神经氨酸酶（NA）的酶促活性以及证明污染蛋白卵清蛋白的水平低于设定阈值为1微克/剂量。 SRID分析需要获得菌株特异性参考HA抗原和抗体，其产生是疫苗开发和释放（特别是在大流行期间）的潜在限速步骤。神经氨酸酶诱导的免疫反应也有助于防止感染。但是，流感疫苗中NA抗原的数量目前尚未量化或标准化。在这里，我们报告了一种用于疫苗分析的方法，与传统的HA定量技术相比，它可以同时快速定量HA和NA水平，同时提供了有关总蛋白质含量的其他有价值的信息。酶消化的疫苗蛋白质通过质谱技术LC-MSE进行了分析，该技术可以绝对定量分析物，包括HA和NA抗原，其他结构流感蛋白和与制造过程相关的鸡蛋蛋白。该方法具有潜在的用途，可以提高参考抗原标准品的准确性，并可以验证配制疫苗中HA含量的标签要求。它还可以用于监视NA和鸡蛋蛋白含量，以监视制造一致性。尽管这是一种有用的方法，具有广泛应用的潜力，但我们还在本文中讨论了该方法的一些固有局限性，以及在将其用作绝对蛋白质定量工具时必须采取的谨慎态度。高可用性的变化。本研究中分析的疫苗中的NA和鸡蛋蛋白浓度表明了当前制造和质量控制测试程序所面临的挑战

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