کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486024 | 1114373 | 2010 | 20 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1-10 mm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202-1205), primarily due to uncertainty around the potential immunogenicity risk from these particles. This article, representing the opinions of a number of industry scientists, aims to further the discussion by developing a common understanding around the technical capabilities, limitations, as well as utility of monitoring this size range; reiterating that the link between aggregation and clinical immunogenicity has not been unequivocally established; and emphasizing that such particles are present in marketed products which remain safe and efficacious despite the lack of monitoring. Measurement of subvisible particulates in the < 10 μm size range has value as an aid in product development and characterization. Limitations in measurement technologies, variability from container/closure, concentration, viscosity, history, and inherent batch heterogeneity, make these measurements unsuitable as specification for release and stability or for comparability, at the present time. Such particles constitute microgram levels of protein with currently monitored sizes â¥Â 10 μm representing the largest fraction. These levels are well below what is detected or reported for other product quality attributes. Subvisible particles remain a product quality attribute that is also qualified in clinical trials.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 8, August 2010, Pages 3302-3321
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 8, August 2010, Pages 3302-3321
نویسندگان
Satish K. Singh, Nataliya Afonina, Michel Awwad, Karoline Bechtold-Peters, Jeffrey T. Blue, Danny Chou, Mary Cromwell, Hans-Juergen Krause, Hanns-Christian Mahler, Brian K. Meyer, Linda Narhi, Doug P. Nesta, Thomas Spitznagel,