Influence of Production Process and Scale on Quality of Polypeptide Drugs: a Case Study on GLP-1 Analogs
Abstract
Purpose null Manufacturing processes for polypeptide/protein drugs are designed to ensure robust quality, efficacy and safety. Process differences introduced by follow-on manufacturers may result in changes in quality and clinical outcomes. This study investigated the impact of production methods on the stability and impurities of liraglutide and semaglutide drug substances/products, and the potential impact on drug quality, efficacy and safety....
Paper Details
Title
Influence of Production Process and Scale on Quality of Polypeptide Drugs: a Case Study on GLP-1 Analogs
Published Date
Jun 8, 2020
Journal
Volume
37
Issue
7
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