Discussion on chemical manufacture and control of multi-component diphtheria-tetanus-pertussis (DTP)-based combined vaccines
10.3760/cma.j.cn112309-20200903-00421
- VernacularTitle:以百白破为基础的多组分联合疫苗药学研究的相关讨论
- Author:
Shuyang GUO
1
;
Su JIN
;
Min LI
Author Information
1. 国家药监局药品审评中心生物制品药学部，北京 100022
- From:
Chinese Journal of Microbiology and Immunology
2020;40(11):889-892
- CountryChina
- Language:Chinese
-
Abstract:
With the development and widespread use of diphtheria-tetanus-pertussis (DTP)-based combined vaccines, the number of vaccinations and the cost of vaccination implementation have gradually decreased, which has a positive and profound impact on implementing immunization programmes and meeting differentiated needs. The development of formulation process is critical to the research on combined vaccines, and a formulation process with good robustness and flexibility plays a vital role in vaccine immunogenicity, antigen compatibility and product stability. This article discussed some common issues in the chemical manufacture and control (CMC) of DTP-based combined vaccines referring to the regulatory consensus of various countries and related organizations.
