کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2484436 | 1114311 | 2016 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Freeze-Drying Above the Glass Transition Temperature in Amorphous Protein Formulations While Maintaining Product Quality and Improving Process Efficiency
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کلمات کلیدی
mAbMFIIgG4Tg′HPSECIgG1 - IgG1 وThermal analysis - آنالیز حرارتیMonoclonal antibody - آنتی بادی مونوکلونالGlass transition - انتقال شیشهMicroflow imaging - تصویربرداری میکرو جریانStability - ثباتDrying - خشک کردنFreeze-Drying - خشککردن انجمادیProcessing - در حال پردازشProtein formulation - فرمول پروتئینLyophilization - لیوفیلیزاسیونHigh-performance size-exclusion chromatography - کروماتوگرافی خروجی با اندازه عملکرد بالا
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
This study explored the ability to conduct primary drying during lyophilization at product temperatures above the glass transition temperature of the maximally freeze-concentrated solution (Tgâ²) in amorphous formulations for four proteins from three different classes. Drying above Tgâ² resulted in significant reductions in lyophilization cycle time. At higher protein concentrations, formulations freeze dried above Tgâ² but below the collapse temperature yielded pharmaceutically acceptable cakes. However, using an immunoglobulin G type 4 monoclonal antibody as an example, we found that as protein concentration decreased, minor extents of collapse were observed in formulations dried at higher temperatures. No other impacts to product quality, physical stability, or chemical stability were observed in this study among the different drying conditions for the different proteins. Drying amorphous formulations above Tgâ², particularly high protein concentration formulations, is a viable means to achieve significant time and cost savings in freeze-drying processes.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 1, January 2016, Pages 40-49
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 1, January 2016, Pages 40-49
نویسندگان
Roberto A. Depaz, Swapnil Pansare, Sajal Manubhai Patel,