کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1222269 | 967859 | 2010 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A validated capillary electrophoresis method to check for batch-to-batch consistency during recombinant human glycosylated interleukin-7 production campaigns
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کلمات کلیدی
E. coliCZEBGEIL-7EOFDABRecombinant human erythropoietin - اریتروپویتین بازآفرینی انسانیEscherichia coli - اشریشیا کُلیValidation - اعتبار سنجیCapillary zone electrophoresis - الکتروفورز منطقه کاپیلاریCapillary electrophoresis - الکتروفورزمویرگیbackground electrolyte - الکترولیت پس زمینهinterleukin-7 - اینترلوکین -7Cho - برایChinese Hamster Ovary - تخمدان هامستر چینیElectroosmotic flow - جریان الکترواسموتیکrhEPO - رپوEuropean Pharmacopoeia - فارماکوپه اروپاییICH - منquality control - کنترل کیفیتInternational Conference on Harmonization - کنفرانس بین المللی هماهنگیGlycoprotein - گلیکوپروتئین
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
This work reports the validation of a simple CZE method to be used in quality control of recombinant human glycosylated interleukin-7 (rhIL-7) batches produced in Chinese Hamster Ovary (CHO) cells. The separation buffer was a 25Â mM sodium borate at pH 10 containing 12Â mM diaminobutane (DAB) used as a dynamic coating agent of the capillary. This method allowed the separation of seven peaks ranging from low to high sialylated glycoforms. An extensive study on conditioning methods of the capillary has been conducted to yield repeatable results. Excellent RSD of EOF mobility (less than 0.6%) was obtained when conditioning included capillary equilibration under virtual analyses and storage in 0.1Â M NaOH overnight. Method specificity has been demonstrated to be able to discriminate different rhIL-7 glycoforms produced in CHO from formulation matrix. Linearity was demonstrated between 0.5 and 4Â mg/mL. LOQ was 0.5Â mg/mL. Repeatability (RSDÂ <Â 1.4 and 3.3% for tm and A%, respectively), intermediate precision of inter-day (RSDÂ <Â 2.1 and 4.5), inter-analyst (RSDÂ <Â 2.0 and 3.0) and inter-equipment (RSDÂ <Â 3.8 and 3.7 for electrophoretic mobility and A%, respectively) were all very satisfactory. Evaluation of robustness revealed that pH and DAB concentration are critical parameters in the method while slight alteration of ionic strength of electrolyte or change of capillary source did not affect the results. Finally the method was shown to provide reliable informations to address comparability studies and batch-to-batch consistency of biomanufactured rhIL-7.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 51, Issue 4, 11 March 2010, Pages 882-888
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 51, Issue 4, 11 March 2010, Pages 882-888
نویسندگان
Youssef Alahmad, Myriam Taverna, Hanane Mobdi, Jérémy Duboeuf, Anne Grégoire, Iann Rancé, Nguyet Thuy Tran,