کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2502843 | 1557405 | 2012 | 11 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Immunogenicity of protein aggregates—Concerns and realities
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موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
علوم دارویی
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چکیده انگلیسی
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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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 431, Issues 1–2, 15 July 2012, Pages 1–11
Journal: International Journal of Pharmaceutics - Volume 431, Issues 1–2, 15 July 2012, Pages 1–11
نویسندگان
Wei Wang, Satish K. Singh, Ning Li, Maria R. Toler, Kevin R. King, Sandeep Nema,