کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10162564 1114334 2014 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Investigations into the Fouling Mechanism of Parvovirus Filters During Filtration of Freeze-Thawed mAb Drug Substance Solutions
ترجمه فارسی عنوان
تحقیقات در مورد مکانیزم رفع فیلترهای پاروویروس در طی فیلتر کردن راه حل های مواد مخدر مؤثر ضد یخ
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
Filtration to remove viruses is one of the single most expensive steps in the production of mAb drug products. Therefore, virus filtration steps should be fully optimized, and any decline in flow rates warrants investigation into the causes of such membrane fouling. In the current study, it was found that freezing and thawing of a mAb bulk drug solution caused a substantial decrease in viral filter membrane flow rate. Freezing and thawing also caused formation of aggregates and particles across a broad size range, including particles that could be detected by microflow imaging (≥1 μm in size). However, removal of these particles offered little protection against flow rate decline during viral filtration. Further investigation revealed that trace amounts of aggregates (ca. 10−6 of the total mass of protein in solution) approximately 20-40 nm in size were primarily responsible for the observed membrane fouling.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 3, March 2014, Pages 890-899
نویسندگان
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