Discussion on chemical manufacture and control of multi-component diphtheria-tetanus-pertussis (DTP)-based combined vaccines / 中华微生物学和免疫学杂志

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.