基于制剂开发的单克隆抗体药物早期成药性研究策略

Research strategy of early druggability of monoclonal antibody based on preparation development

单克隆抗体(单抗)药物已经成为市场上增长最快的一类治疗药物,但开发用于治疗的单抗仍然具有挑战性。此文从制剂开发角度,根据单抗序列分析、高通量实验性评估综述了单抗药物早期成药性研究策略,旨在为筛选鉴定出易于生产及稳定的候选治疗性单抗药物提供参考。

Monoclonal antibodies have become the fastest-growing class of therapeutics on the market,but it is still challenging to develop them for therapeutic applications.From the perspective of preparation development,this article reviews the research strategy of early druggability of monoclonal antibody drugs by sequence analysis and high-throughput experimental evaluation,aiming to provide reference for screening and identifying candidate therapeutic monoclonal antibody drugs that are easy to produce and stable.