Analytical procedure changes in the lifecycle management of biological products:regulatory consideration and case studies
LI Yi-jun
KOU Ya-zhen
WEI Kai-kun
WEI Wei
Abstract：Quality control of biological products is a keypoint of their pharmaceutical research and evaluation,which runs through the whole life-cycle of the drug management.With the development of analytical technologies related to biological products and the accumulation of post-marketing product knowledge,pharmaceutical companies can continuously improve pharmaceutical analytical procedures and enhance quality risk management.This paper discusses the review considerations for the changes of analytical methods for therapeutic biological products from a regulatory perspective,and shares several typical cases of analytical method changes,so as to provide reference for pharmaceutical companies to continuously improve drug quality control and complete analytical procedure changes submission.
Keywords：therapeutic biological productsanalytical procedurelifecycle managementpost-approval chemical manufacturing and control changes
Publication Date：2024-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1102-1108 )