Immunogenicity of protein aggregates鈥擟oncerns and realities
- 作者：Wei Wang ; wei.2.wang@pfizer.com ; Satish K. Singh ; Ning Li ; Maria R. Toler ; Kevin R. King ; Sandeep Nema
- 关键词：Aggregation ; Particulates ; Subvisible ; Vaccine ; Adjuvant
- 刊名：International Journal of Pharmaceutics
- 出版年：2012
- 期刊代码：24_03785173
- 类别：pha
- 出版时间：15 July, 2012
- 卷：431
- 期：1-2
- 页码：1-11
- 文件大小：497 K
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.