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肺炎球菌血清型7F在疫苗结合中的表征

James Z Deng¹, Xiujuan Jia², Chengli Zong³

¹Vaccine Analytical Research & Development, 770 Sumneytown Pike, P. O. Box 4, West Point, PA, WP46-3305, 19486, USA. james_deng@merck.com.

Glycoconjugate journal

|July 4, 2023

概括

开发了染色学方法来表征Streptococcus pneumoniae血清型7F多糖和它的结合物. 这些方法支持开发一种新的15肺炎球菌合疫苗 (PCV15).

科学领域:

微生物学微生物学
疫苗开发疫苗开发
分析化学分析化学

背景情况:

肺炎链球菌 (Streptococcus pneumoniae) 是一种主要的细菌病原体,导致侵入性肺炎球菌病 (IPD).
肺炎球菌囊多糖体 (CPS) 是关键的毒性因素,7F血清型是特别侵入性的.
血清型7F包含在当前的疫苗中,如VAXNEUVANCE和PREVNAR 20,强调了它的重要性.

研究的目的:

开发和验证用于表征7F多糖和其合物的染色学方法.
支持开发一种新的15肺炎球菌联合疫苗 (PCV15) 的过程.

主要方法:

使用紫外线,光散射和折射率检测的尺寸排除色谱 (SEC) 进行多糖类分析 (度,尺寸,形状).
逆相超高性能液体色谱 (RP-UPLC) 用于结合体分析 (单糖组成,结合度).

主要成果:

已建立的SEC方法用于对7F多糖的综合分析.
开发了RP-UPLC方法,以详细描述肺炎球菌结合物组成和结合.
结合的色谱数据为肺炎球菌结合物及其制造过程提供了关键的见解.

结论:

染色学技术对于肺炎球菌多糖和结合物的强有力的表征至关重要.
这些验证的方法对于PCV15疫苗的成功开发和质量控制至关重要.
这项研究证明了SEC和RP-UPLC在促进肺炎球菌疫苗研究和制造方面的实用性.

关键词:

动态光散射 (DLS) 是一种多角度光散射 (MALS) 是一种光散射技术.肺炎球菌的囊型多糖化物7F 肺炎球菌结合疫苗的结合疫苗尺寸排除色谱 (SEC) 是一种尺寸排除色谱.超高性能液体色谱 (UPLC) 是一种超高性能液体色谱.

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