Common issues and review considerations for the packaging systems of therapeutic recombinant biological products
WU Yong-kai
LI Qian
WEI Wei
HE Wu
Abstract：With the rapid development of the biologics industry,therapeutic recombinant biologics have become increasingly prominent in disease treatment.As an integral part of pharmaceuticals,packaging systems play a crucial role in ensuring the safety,efficacy,and quality stability of drugs.However,during the actual review process,it has been found that there are still many common issues in research related to packaging systems that may affect drug quality and patient medication safety.This article summarizes common issues of packaging systems of therapeutic recombinant biologics in the marketing application,including the joint review of drug-device combination products,compatibility,and sealing,based on relevant domestic and international regulatory guidelines and review practices,and provides an in-depth analysis of review concerns,with the aim of helping applicants improve the quality of application materials.
Keywords：therapeutic recombinant biologicspackaging systemsreview considerations
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2680-2685 )