免疫原性
审查
蛋白质聚集
风险分析(工程)
生化工程
计算生物学
化学
生物
业务
政治学
工程类
免疫学
免疫系统
生物化学
法学
作者
Wei Wang,Satish K. Singh,Ning Li,Maria R. Toler,Kevin R. King,Sandeep Nema
标识
DOI:10.1016/j.ijpharm.2012.04.040
摘要
Protein aggregation is one of the key challenges in the development of protein biotherapeutics. It is a critical product quality issue as well as a potential safety concern due to the increased immunogenicity potential of these aggregates. The overwhelming safety concern has led to an increased development effort and regulatory scrutiny in recent years. The main purposes of this review are to examine the literature data on the relationship between protein aggregates and immunogenicity, to highlight the linkage and existing inconsistencies/uncertainties, and to propose directions for future investigations/development.
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