Progress and challenges in the implementation of 3Rs quality control approaches in WHO guidelines on biologicals
HE Qing
TAN De-jiang
MA Xiao
ZHENG Yi-yang
LIU Si-han
ZHANG Yu
WANG Jun-zhi
Abstract：WHO guidelines on biologicals and vaccines are fully integrating and implementing the 3Rs quality control approaches to replace,optimize and reduce the use of animals in five quality control fields including endotoxin/pyrogen,neurovirulence,adventitious agents,potency and immunogenicity,specific toxicity.At present,3Rs quality control approaches have made great progress in the field of endotoxin/pyrogen,and global regulators and pharmaceutical companies are developing and applying non-animal technologies,e.g.,monocyte activation test(MAT),recombinant factor C bacterial endotoxin test(rFC BET),for detecting endotoxin/pyrogen,which have also made some progress in other fields(neurovirulence,adventitious agents,potency and immunogenicity,specific toxicity).The further development of 3Rs quality control approaches is facing some common challenges,such as the lack of international harmonized regulatory,standards and technical validation guidelines,how to scientifically evaluate the comparability and relevance of different testing technologies,and how to promote and popularize advanced testing technologies globally.
Keywords：replacementrefinementreductionbiologicalsvaccines
Publication Date：2024-08-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1659-1664 )