肺炎球菌疫苗生产菌种肺炎链球菌种子批质量控制

Quality control of seed batch of Streptococcus pneumoniae for pneumococcal vaccine production

肺炎球菌多糖疫苗或多糖蛋白结合疫苗在预防肺炎球菌性疾病中发挥着重要的作用。肺炎链球菌是肺炎球菌疫苗研制、生产的重要原材料,也是国家重要的战略储备资源,其质量直接或间接影响终产品肺炎球菌疫苗的质量、安全和效力。因此,严格控制肺炎球菌疫苗生产用肺炎链球菌的质量至关重要。本文对肺炎球菌疫苗生产用肺炎链球菌种子批的传统检定方法和分子生物学检定方法(16S rRNA序列测定、基于PCR的血清分型、多位点序列分型、脉冲场凝胶电泳分型和全基因组序列测序)进行概述,并对这些方法的优缺点进行讨论,以期为完善生产用肺炎链球菌种的质控方法和质量标准提供帮助。

Pneumococcal polysaccharide vaccine or polysaccharide conjugate vaccine plays an important role in preventing pneumococcal diseases.Streptococcus pneumoniae is an important raw material for the development and production of pneumococcal vaccine,as well as an important national strategic reserve resource.Its quality directly or indirectly affects the quality,safety and efficacy of the final product pneumococcal vaccine.Therefore,it is very important to strictly control the quality of Streptococcus pneumoniae used for the production of pneumococcal vaccine.In this paper,the traditional quality control method and molecular biological method(16S rRNA gene sequencing,PCR-based serotyping,multilocus sequence typing,pulsed field gel electrophoresis and whole genome sequencing)used for the quality control of the seed batch of Streptococcus pneumoniae for pneumococcal vaccine production are summarized,and the advantages and disadvantages of these methods are discussed,in order to provide supports for the improvement of quality control methods and quality standards of Streptococcus pneumoniae for pneumococcal vaccine production.