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近红外光谱和红外光谱在过敏疫苗生产质量控制中的潜在应用。

Potential uses of NIR and IR spectroscopy in quality control of allergy vaccine production.

作者信息

Zheng Yiwu, Lai Xuxin

机构信息

ALK-Abello A/S, Guangzhou, PR China.

出版信息

Arb Paul Ehrlich Inst Bundesinstitut Impfstoffe Biomed Arzneim Langen Hess. 2009;96:112-9; discussion 120.

Abstract

BACKGROUND

Compared to conventional methods, infrared spectroscopy offers many potential uses in quality control of vaccine production. A major advantage is that the technique is non-invasive and non-destructive. In this study several possible uses of infrared spectroscopy in the control of allergy vaccines were investigated.

METHODS

Near infrared spectroscopy (NIR) was applied to determine the aluminium content in aluminium hydroxide formulations, the particle size of aluminium hydroxide, the protein adsorption level on aluminium adjuvant and the moisture content of lyophilized vaccines. Mid infrared spectroscopy (IR) was used to investigate protein structural changes during adsorption and release from aluminium hydroxide and the stability of the complex.

RESULTS

Based on the calibration models of NIR in different applications, it was demonstrated that NIR had great advantages for application in vaccine production. IR also showed advantages on structural analysis of adsorbed proteins.

DISCUSSION

Infrared spectroscopy as a physical, non-invasive, non-destructive method should receive more attention in vaccine research and production.

摘要

背景

与传统方法相比,红外光谱在疫苗生产质量控制方面有许多潜在用途。一个主要优点是该技术是非侵入性和非破坏性的。在本研究中,对红外光谱在过敏疫苗控制中的几种可能用途进行了研究。

方法

应用近红外光谱(NIR)来测定氢氧化铝制剂中的铝含量、氢氧化铝的粒径、铝佐剂上的蛋白质吸附水平以及冻干疫苗的水分含量。中红外光谱(IR)用于研究蛋白质在氢氧化铝上吸附和释放过程中的结构变化以及复合物的稳定性。

结果

基于不同应用中近红外光谱的校准模型,证明近红外光谱在疫苗生产应用中具有很大优势。红外光谱在吸附蛋白质的结构分析方面也显示出优势。

讨论

红外光谱作为一种物理的、非侵入性、非破坏性的方法,在疫苗研究和生产中应受到更多关注。

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