Bacterial Endotoxin Testing | 合法醫療器材資訊網

Endotoxinsarethelipopolysaccharide(LPS)structuralcomponentofthecellwallofGram-negativebacteria.Theyaremadeupofthreemainparts:TheOantigen,​ ...

Due to the recent COVID pandemic, an increasing number of approved cell and gene therapies, and other large molecule treatments, there has been increased interest in understanding the testing requirements and best methods for vaccines and biologics. Due to their unique nature, these products present new challenges for quality control. Some have very short half-lives and require rapid testing some components may enhance or inhibit certain pyrogen or endotoxin testing reagents or be inappropriate for testing in live animals. Please visit the QC Insider® Toolbox[1] to find useful information regarding each of these topics including: “Endotoxin Detection in Cell, Gene Therapy and Combination Products” presentation, “Endotoxin Testing for Biologics” webinar, “Endotoxin Testing for Vaccines.”

In the United States, such products are regulated under the authority of the Food, Drug, and Cosmetic Act by the U.S. Food and Drug ...