从“质量源于设计”角度浅谈多糖-蛋白结合疫苗药学研发的考虑

The CMC consideration of the development of conjugate vaccines from the view of quality by design

多糖-蛋白结合疫苗生产工艺步骤多且涉及多步化学反应,产品结构复杂,关键质量属性极大程度依赖于早期研发确定的生产工艺。本文基于"质量源于设计(Qb D)"的理念,围绕对多糖-蛋白结合疫苗关键质量属性的分析和认识,讨论如何在早期研发阶段筛选出适宜的生产工艺、在临床验证中建立适宜的质量标准。

The manufacture process of conjugated vaccines involves multi-step chemistry reactions and the physicochemieal characterization of the final product is complex. The critical quality attribute （CQA） highly depends on the process perimeters established during the pharmaceutical development. Based on the concept of ＂quality by design （QbD）＂, the CQA of the conjugated vaccines was analyzed, and the ways to explore proper manufacture process and establish specifications on the foundation of the CQA and the clinical trail data were discussed.