Circular of CDE Publication on the Technical Guidelines for Pharmacological Research and Evaluation of Polysaccharide Conjugate Vaccines (for Trial Implementation) (No. 51 of 2024)

The Center for Drug Evaluation (CDE) issued technical guidelines on pharmaceutical research and evaluation of covalently bonded polysaccharide conjugate vaccines as well as combination vaccines that are developed using these vaccines as components. These guidelines provide recommendations and information on production strains and seed lots, culture media and raw materials, various aspects of the production process, quality research and standards, stability studies, and packaging and containers. The document notes that research in recent years has led to further understanding on the mechanism of action for these vaccines, and that future research will include new pathogen development, new carrier proteins with more T cell epitopes or additional functions, new binding methods, and other areas.

Original link: https://www.cde.org.cn/main/news/viewInfoCommon/6f97839c1158101e7b20c704a401f915