کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2487666 | 1114426 | 2007 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A simple method for the detection of insoluble aggregates in protein formulations
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
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چکیده انگلیسی
Low levels of insoluble aggregates in protein formulations can sometimes only be detected by visual inspection. To overcome the subjectivity and other limitations associated with visual inspection, a microscopic technique based on filtration/staining was developed. This method is a simple modification of the microscopic method listed in USP for particulate matter analysis and it provides two major advantages over the original method. First, particles are easier to see because of the staining. Second, this method is specific to protein aggregates so that it avoids interferences from other nonproteinaceous particles. In addition, this method does not have any restrictions on the rheological or optical properties of the samples. This method can be a useful tool in protein formulation development as demonstrated by its application in the evaluation of monoclonal antibody formulations. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96: 1840-1843, 2007
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 7, July 2007, Pages 1840-1843
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 7, July 2007, Pages 1840-1843
نویسندگان
B.e.i. Li, Jose Flores, Vincent Corvari,