کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1207091 | 965255 | 2009 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Viral clearance using monoliths
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
Clearance of biological impurities is an essential part of the manufacture of biotechnology-derived products such as monoclonal antibodies (mAbs). Salt is required during manufacture to solubilize the mAb product and stabilize it against aggregation, but salt can be a problem later during impurity clearance operations. In this work, the use of a traditional quaternary amine (Q) monolith, and a new salt-tolerant monolith were evaluated for the clearance of pathogenic impurities including viruses, DNA, and host-cell protein (HCP). The impact of flow rate, salt concentration, and presence of mixtures of impurities in the feed stream were evaluated. Both monoliths cleared DNA to the limit of detection at all salt concentrations, and both cleared virus and HCP equally well at no salt. At intermediate salt, clearance of HCP was greater for the salt-tolerant monolith, and only the salt-tolerant monolith cleared virus at elevated salt. In conclusion, monoliths successfully trapped impurities such as DNA, host-cell protein, and viruses, and at flow rates far greater than traditional chromatography columns packed with beads.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography A - Volume 1216, Issue 13, 27 March 2009, Pages 2621-2624
Journal: Journal of Chromatography A - Volume 1216, Issue 13, 27 March 2009, Pages 2621-2624
نویسندگان
Mark R. Etzel, William T. Riordan,