Considerations on establishing quality standards of specific human immunoglobulin products
JIA Yan-hua
JIA Dong-chen
YU Peng-li
WU Zhou-yi
Abstract：Drug quality standards are the criteria for measuring the intrinsic quality attributes of pharma-ceuticals.They represent the final outcomes and legal embodiment of drug efficacy,safety,and quality control,spanning the entire lifecycle of drug development.The purpose of drug quality standards is to provide patients with consistent inter-batch drug quality,ensure controllable drug quality,and thereby guarantee the safety and efficacy of medications for patients.In the development of blood products derived from human blood,specific human immunoglobulin products possess unique pharmacological characteristics,and their production processes and quality control can fully leverage the mature systems established for conventional human immunoglobulins.At the current stage,specific human immunoglobulin products in China demonstrate significant market development potential.This article systematically reviewed the quality standards for specific immunoglobulin products included in the Chinese Pharmacopoeia 2025 edition,compares them with corresponding varieties in the European Pharmacopoeia and the United States Pharmacopoeia,and elaborates on the key technical requirements involved in relevant quality control items,taking into account the current state of research and development of specific human immunoglobulin in China.
Keywords：specific human immunoglobulinhuman immunoglobulinquality standards
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：3( 2657-2659 )