کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8514755 | 1556511 | 2016 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Comprehensive Evaluation of Nanoparticle Tracking Analysis (NanoSight) for Characterization of Proteinaceous Submicron Particles
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کلمات کلیدی
DLSRMMSE-HPLCmAbIgGMFIEDRNTAMTLDetection threshold - آستانه تشخیصMonoclonal antibody - آنتی بادی مونوکلونالSize-exclusion HPLC - اندازه خروجی HPLCimmunoglobulin G - ایمونوگلوبولین GNanoparticle tracking analysis - تجزیه و تحلیل ردیابی نانو ذراتprotein aggregation - تجمع پروتئینMicroflow imaging - تصویربرداری میکرو جریانStability - ثباتProtein formulation - فرمول پروتئینMEPs - نمایندگان مجلسDynamic Light Scattering - پراکندگی نور دینامیکیhigh-performance liquid chromatography - کروماتوگرافی مایعی کاراHPLC - کروماتوگرافی مایعی کارا
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
Nanoparticle tracking analysis (NTA) has attracted great interest for application in the field of submicron particle characterization for biopharmaceuticals. It has the virtue of direct sample visualization and particle-by-particle tracking, but the complexity of method development has limited its routine applicability. We systematically evaluated data collection and processing parameters as well as sample handling methods using shake-stressed protein samples. The camera shutter and gain were identified as the key factors influencing NTA results. We also demonstrated that sample filtration was necessary for NTA analysis if there were high numbers of micron particles, whereas the choice of filter membrane was critical for data quality. Sample dilution into corresponding formulation buffer did not affect particle size distributions in our study. Finally, NTA analysis exhibited excellent repeatability in intraday comparison of multiple measurements on the same sample and interday comparison on different batches of samples. Shaking-induced protein aggregation could also be sensitively monitored by NTA. In conclusion, NTA analysis can be used as a robust stability-indicating method for the characterization of proteinaceous submicron particles and thereby complement other analytical methods, provided that consistent sample handling and parametric settings are established for the specific case study.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 11, November 2016, Pages 3366-3375
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 11, November 2016, Pages 3366-3375
نویسندگان
Xinsheng Tian, M. Reza Nejadnik, Dorrit Baunsgaard, Anette Henriksen, Christian Rischel, Wim Jiskoot,