The CMC consideration of the development of conjugate vaccines from the view of quality by design
LI Min
XU Jia-qi
Abstract：The manufacture process of conjugated vaccines involves multi-step chemistry reactions and the physicochemical 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.
Keywords：conjugate vaccinequality by designcritical quality attributeprocess developmentspecifications
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1623-1627 )