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Quality control of routine, experimental and real-time aged diphtheria toxoids by in vitro analytical techniques

机译：通过体外分析技术对常规，实验和实时老化的白喉类毒素的质量控制

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Physicochemical and immunochemical techniques can be used to assess the quality of diphtheria toxoid vaccines. In a previous paper [Metz B, Jiskoot W, Hennink WE, Crommelin DJA, Kersten GFA. Physicochemical and immunochemical techniques predict the quality of diphtheria toxoid vaccines. Vaccine 2003;22(2):156-67], techniques were introduced which indicated toxoid quality with respect to safety and potency: SDS-PAGE, primary amino group determination, fluorescence/denaturation, circular dichroism and biosensor analyses. These analyses were performed with experimental toxoids from one toxin batch. In the present study, the quality of regular vaccine batches of different manufacturers, the properties of real-time aged products and a number of experimental toxoids were investigated, using the above-mentioned analytical techniques. We had the unique opportunity to analyse toxoids that were up to 40 years old. The real-time aged diphtheria toxoids showed hardly any structural differences as compared to the recently prepared products in both the analytical chemical techniques and the conventional potency and safety tests. The analytical assays discriminated between regular diphtheria toxoids and experimental toxoids prepared by methylation, acetylation or glutaraldehyde treatment. The analytical data showed a clear correlation with potency and safety of these toxoids. Based on the results, we refined the described physicochemical and immunochemical criteria that a standard diphtheria toxoid has to meet. We recommend further validation of these techniques for quality control of diphtheria toxoid vaccine because of their high precision and easy performance as compared to conventional in vivo procedures.
机译：物理化学和免疫化学技术可用于评估白喉类毒素疫苗的质量。在先前的论文中[Metz B，Jiskoot W，He​​nnink WE，Crommelin DJA和Kersten GFA。物理化学和免疫化学技术可预测白喉类毒素疫苗的质量。 Vaccine 2003; 22（2）：156-67]，介绍了在安全性和效力方面指示类毒素质量的技术：SDS-PAGE，伯氨基测定，荧光/变性，圆二色性和生物传感器分析。这些分析是用一批毒素中的实验类毒素进行的。在本研究中，使用上述分析技术研究了不同制造商的常规疫苗批次的质量，实时老化产品的特性以及许多实验性类毒素。我们有独特的机会来分析长达40年的类毒素。与最近制备的产品相比，实时老化的白喉类毒素在分析化学技术以及常规效能和安全性测试方面几乎没有任何结构差异。分析测定区分了常规白喉类毒素和通过甲基化，乙酰化或戊二醛处理制备的实验类毒素。分析数据表明，这些类毒素的效力和安全性具有明显的相关性。基于结果，我们完善了标准白喉类毒素必须满足的所述物理化学和免疫化学标准。我们建议对这些技术进行进一步验证，以用于白喉类毒素疫苗的质量控制，因为与常规的体内操作相比，它们具有很高的精确度和简便的性能。

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