کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162633 | 1114336 | 2014 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
LabelâFree Flow Cytometry Analysis of Subvisible Aggregates in Liquid IgG1 Antibody Formulations
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کلمات کلیدی
Monoclonal antibody - آنتی بادی مونوکلونالParticle sizing - اندازه ذراتAnalytical biochemistry - بیوشیمی تحلیلیprotein aggregation - تجمع پروتئینMicroflow imaging - تصویربرداری میکرو جریانRefractive index - ضریب شکستProtein formulation - فرمول پروتئینFlow cytometry - فلوسیتومتریLight obscuration - نور مضر
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The objective of this study was to characterize and quantify labelâfree subvisible antibody particles in different formulations based on their size and physical properties by flow cytometry. Protein subvisible particles were prepared under various stress conditions and analyzed by applying different analytical techniques [light obscuration (LO), microflow imaging (MFI), and flow cytometry (FACS)] for the detection of aggregates. The capability of the FACS method to detect and count subvisible particles was evaluated and benchmarked against conventional techniques. FACS can analyze particles down to 500 nm reducing the gap between sizeâexclusion chromatography and LO. The applied methods of FACS, LO, and MFI displayed a proportional correlation between the total particle counts, however, FACS can provide additional information on the structural characteristics of such aggregated particles. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:90-99, 2014
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 1, January 2014, Pages 90-99
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 1, January 2014, Pages 90-99
نویسندگان
Hirotaka Nishi, Roman Mathäs, Robert Fürst, Gerhard Winter,