Considerations for elemental impurity control strategies of recombinant protein products based on ICH Q3D(R2)
KOU Ya-zhen
WEI Wei
HE Wu
Abstract：Elemental impurities in recombinant protein products,as significant process-related impurities,play a pivotal role in product safety and quality attributes.The 2025 edition of the Chinese Pharmacopoeia with ICH Q3D(R2):Elemental Impurities,provides crucial guidance for controlling elemental impurities in recombinant protein products.By summarizing and analyzing the relevant requirements of current regulations,combined with considerations on the specific challenges for recombinant protein products,this paper aims to establish a risk-based,comprehensive impurity control strategy throughout the entire process for drug developers'reference.
Keywords：recombinant proteinelemental impuritiesrisk assessmentcontrol strategy
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( 2674-2679 )