CMC research and evaluation considerations of fatty acid chain-modified glucagon-like peptide 1 drugs
ZHAO Jing
WEI Wei
WEI Kai-kun
Abstract：Glucagon like peptide 1(GLP-1)can inhibit the elevation of glucagon,inhibit gastric acid secretion,and slow down gastrointestinal peristalsis.However,the plasma half-life of GLP-1 is only a few minutes to a few hours.Frequent and high-dose administration are required to achieve therapeutic effects which will increase the risk of adverse effects.Therefore,long acting is an important research interest for GLP-1 drugs.Fatty acid chain modification is the widely used long-acting strategy for GLP-1 drugs due to its advantages of definite modification sites,low heterogeneity of modified products,low loss of biological activity,and low toxic effects.To provide references for the CMC research and evaluation of fatty acid chain-modified GLP-1 drugs and other fatty acid chain-modified peptide drugs,this article shares the experience accumulated in the evaluation of fatty acid chain-modified drugs and proposes the evaluation considerations for recombinant fatty acid chain-modified GLP-1 drugs from the perspectives of raw materials for production,production processes,quality control,and stability research.
Keywords：fatty acid chain modificationglucagon-like peptide 1CMC researchlong actingevaluation considerations
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2507-2512 )