کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8485678 | 1551746 | 2018 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Bivalent rLP2086 (Trumenba®): Development of a well-characterized vaccine through commercialization
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کلمات کلیدی
Bivalent rLP2086DOEHCPNeisseria meningitidis serogroup BRP-HPLCNMBFDAfHBPrPHUS Food and Drug Administration - اداره غذا و داروی ایالات متحدهWorst case - بدترین حالتELISA - تست الیزاEnzyme-linked immunosorbent assay - تست الیزاProcess development - توسعه فرایندDesign of experiments - طراحی آزمایشاتProcess characterization - مشخصات پردازشDrug substance - مواد مخدرNeisseria meningitidis - نایسریا مننژیتیس، مننگوکوکVaccine - واکسنFactor H binding protein - پروتئین اتصال دهنده فاکتور Hhost cell proteins - پروتئین های سلولی میزبانreversed-phase high-performance liquid chromatography - کروماتوگرافی مایع با کارایی با رزولوشن بالا
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
The phrase “Process is the Product” is often applied to biologics, including multicomponent vaccines composed of complex components that evade complete characterization. Vaccine production processes must be defined and locked early in the development cycle to ensure consistent quality of the vaccine throughout scale-up, clinical studies, and commercialization. This approach of front-loading the development work helped facilitate the accelerated approval of the Biologic License Application for the well-characterized vaccine bivalent rLP2086 (Trumenba®, Pfizer Inc) in 2014 under Breakthrough Therapy Designation. Bivalent rLP2086 contains two rLP2086 antigens and is licensed for the prevention of meningococcal meningitis disease caused by Neisseria meningitidis serogroup B in individuals 10-25Â years of age in the United States. This paper discusses the development of the manufacturing process of the two antigens for the purpose of making it amenable to any manufacturing facility. For the journey to commercialization, the operating model used to manage this highly accelerated program led to a framework that ensured “right the first time” execution, robust process characterization, and proactive process monitoring. This framework enabled quick problem identification and proactive resolutions, resulting in a robust control strategy for the commercial process.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 36, Issue 22, 24 May 2018, Pages 3180-3189
Journal: Vaccine - Volume 36, Issue 22, 24 May 2018, Pages 3180-3189
نویسندگان
Khurram Sunasara, John Cundy, Sriram Srinivasan, Brad Evans, Weiqiang Sun, Scott Cook, Eric Bortell, John Farley, Daniel Griffin, Michele Bailey Piatchek, Katherine Arch-Douglas,