组分百日咳疫苗药学评价的一般考虑

General considerations on CMC evaluation for component pertussis vaccines

组分百日咳疫苗与共纯化百日咳疫苗相比,成分更明确、纯度更高、更易于工艺控制,已成为目前百日咳疫苗开发的主要趋势。本文从生产工艺、质量研究等方面,对组分百日咳疫苗在早期研发及临床申报阶段的药学研究常见问题进行探讨。

Compared with co-purified pertussis vaccine, component pertussis vaccine has clearer composition, higher purity and easier process control, which has become the main trend of pertussis vaccine development. However, due to the diversity of pertussis antigen components, the complexity of production process, especially the purification and detoxification, these poses great challenges for vaccine development and evaluation of chemical manufacture and controls(CMC). This paper discusses the common CMC problems of component pertussis vaccine in the early stage of development and the clinical application, including production technology and quality research.