速递｜重磅！CDE发布《重组胰高血糖素样肽-1受体激动剂药学研究与评价技术指导原则（试行）》

Core Viewpoint - The article outlines the technical guidance principles for the pharmaceutical research and evaluation of recombinant glucagon-like peptide-1 (GLP-1) receptor agonists, emphasizing the importance of quality management throughout the product lifecycle and the need for rigorous research on impurities and production processes [5][8]. Summary by Sections Introduction - GLP-1 is a hormone that plays a significant role in blood sugar control and weight management through its interaction with GLP-1 receptors. The guidance focuses on the characteristics of recombinant GLP-1 receptor agonists and the key research areas for product registration [8]. Scope of Application - The guidance applies to recombinant DNA technology-produced GLP-1 receptor agonists, categorized into three classes based on their structure and production processes: GLP-1 short peptides, chemically modified GLP-1 receptor agonists, and GLP-1 receptor agonists fused with other proteins [9][10]. General Principles - Emphasizes a quality-by-design approach in the development of recombinant GLP-1 receptor agonists, including research strategies, lifecycle management, and impurity studies [10][12][13]. Raw Liquid Production Process - Highlights the importance of raw materials in product quality, including seed batches and production enzymes. It stresses the need for risk assessment and compliance with pharmacopoeia standards [14][15][16]. Formulation and Production Process - Discusses the significance of formulation in ensuring drug stability and patient compliance. It covers the development of single-dose and multi-dose formulations, including considerations for excipients and microbial safety [25][26][27]. Quality Research and Quality Control - Quality research should align with the principles of recombinant protein drugs, focusing on structural confirmation, impurity analysis, and the impact of modifications on biological activity [32][33][38]. Packaging System - The packaging system's integrity and compatibility with the product are crucial for maintaining quality and stability [45]. Stability Research - Stability studies are essential throughout the product lifecycle to support storage, transportation, and usage, ensuring microbial safety and product efficacy [46].