结构分析技术及其在重组疫苗质量研究中的应用

重组疫苗抗原结构以及生产工艺的复杂性,对重组疫苗的质量控制提出了更高的要求。重组疫苗抗原保持天然构象的程度直接决定其诱导免疫应答的程度,从而最终影响疫苗的有效性。对抗原开展多角度、多尺度、多方位的结构研究不仅能够完成抗原的结构确证,还有助于了解产品的关键质量属性,从而建立有效的质量控制体系。此文综述了三维结构测定、抗原表位鉴定及颗粒性分析等多种结构分析技术,以及结构分析在重组疫苗质量研究中的应用。

Structural analysis techniques and their application in quality studies of recombinant vaccines

Due to the complexity of antigen structure and production processes, higher requirements are put demanded for quality control of recombinant vaccine. The degree to which recombinant vaccine antigens maintain their natural conformation directly determines the degree of  immune response induced by recombinant vaccine antigens, thus ultimately affects the effectiveness of vaccine. In-depth antigen structure studies of various perspectives not only fulfill structure confirmation, but also help to understand the critical quality attributes of products, so as to establish an effective quality control system. In this review, various structural analysis techniques for three-dimensional structure determination, epitope identification and granular analysis are reviewed, in combination with the applications of structural analysis in the quality study of recombinant vaccines.