کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8369213 | 1543040 | 2012 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Comparability studies of new 3rd generation recombinant human factor VIII GreenGene F after improvement of formulation and viral inactivation/removal process
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کلمات کلیدی
SECsize exclusion HPLCrFVIIIS/DFVIIIRP-HPLCBCAvWFAPTTReversed phase HPLC - HPLC فاز برگشتیSDS-PAGE - الکتروفورز ژل پلی آکریل آمیدbicinchoninic acid - بیسینکنینیک اسیدSolvent/detergent - حلال / مواد شویندهProtein characteristics - خصوصیات پروتئینcircular dichroism - رنگ تابی دورانیactivated partial thromboplastin time - زمان ترومبوپلاستین جزئی فعال شده استVon Willebrand factor - عامل فون ویلبراندViral inactivation - غیر فعال کردن ویروسیcomparability - قابلیت مقایسهDrug substance - مواد مخدرDrug product - مواد مخدرhigh-performance liquid chromatography - کروماتوگرافی مایعی کاراHPLC - کروماتوگرافی مایعی کارا
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوشیمی، ژنتیک و زیست شناسی مولکولی (عمومی)
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چکیده انگلیسی
A new 3rd generation recombinant factor VIII (rFVIII), GreenGene F (WHO INN: beroctocog alfa), which is a highly homogenous B-domain deleted FVIII protein comprising of two peptides as heavy chain (A1 and A2 domain) and light chain (A3, C1, and C2 domain) at 80 and 90 kDa, was developed from its predecessor product GreenGene (2nd generation product previously approved by Korea FDA after clinical studies in South Korea) by process improvements of i) addition of Solvent/Detergent treatment for virus inactivation, ii) nanofiltration (20 nm pore size) for viral removal and iii) alterations to an albumin-free formulation to minimize the risk of viral contamination. An assessment of comparability between the two products was made to see if process improvements for safer product manufacturing affected the rFVIII structural and functional characteristics. Physicochemical and physiological characteristics were observed, in vivo efficacy following a single intravenous administration to FVIII knock-out mice and toxicity by various GLP in vivo tests were evaluated. All results showed equivalence, proving that no changes in protein characteristics of rFVIII occurred from process changes in formulation, viral inactivation, and viral removal which minimize the risk of pathogen transmission to enhance safety.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Biologicals - Volume 40, Issue 6, November 2012, Pages 405-414
Journal: Biologicals - Volume 40, Issue 6, November 2012, Pages 405-414
نویسندگان
Sang Hoon Paik, Yong Jae Kim, Sang Kyul Han, Ji-youn Kim, Hanna Park, Young In Park,