کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10158189 | 1666516 | 2018 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Significant Drying Time Reduction Using Microwave-Assisted Freeze-Drying for a Monoclonal Antibody
ترجمه فارسی عنوان
کاهش زمان قابل توجهی از خشک شدن با استفاده از مایکروویو برای آنتی بادی منوکلونال
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کلمات کلیدی
HP-SECHPWHP-β-CDmAb2-hydroxypropyl-β-cyclodextrinMFDSSAMonoclonal antibody - آنتی بادی مونوکلونالStability - ثباتSolid state - حالت جامدDrying - خشک کردنCFD - دینامیک سیالاتSpecific surface area - سطح خاصGlass - شیشه Excipients - عضلاتLyophilization - لیوفیلیزاسیونmicrowave - مایکروویو یا میکروویوX-ray diffraction - پراش اشعه ایکسXRD - پراش اشعه ایکسProteins - پروتئین هاHigh-performance size exclusion chromatography - کروماتوگرافی خروج با اندازه کافی بزرگFreeze-drying/lyophilization - یخ زدایی / لیوفیلیزاسیون
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
Microwave-assisted freeze-drying (MFD) is a rapid drying process well known in food technology. However, little is known about its application to biologicals. In this study, we investigated the applicability and feasibility of this technology to different monoclonal antibody formulations and the influence on the resulting product properties. Moreover, one of our main objectives was to study if significant reductions in drying times could be achieved. In addition, the effect of the drying process on the accelerated stability of a sucrose-based antibody formulation at 40°C and 25°C over 12 weeks was investigated. MFD resulted in drying time reduction >75%. For all model formulations, cake appearance and solid state properties were found to be comparable to standard lyophilized products. These formulations covered a wider range of lyophilization excipients comprising sucrose and trehalose, semi-crystalline forming solids like mannitol:sucrose mixtures and others like arginine phosphate and a mixture of 2-hydroxypropyl-β-cyclodextrin with sucrose. Moreover, comparable low changes in relative monomer content, the relative amount of soluble aggregates and cumulative particles â¥1 μm per mL were observed over 12 weeks of storage, regardless of the drying technology. This makes MFD a promising innovative alternative for the rapid production of freeze-dried biologicals while maintaining product quality.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 10, October 2018, Pages 2538-2543
Journal: Journal of Pharmaceutical Sciences - Volume 107, Issue 10, October 2018, Pages 2538-2543
نویسندگان
Julian H. Gitter, Raimund Geidobler, Ingo Presser, Gerhard Winter,