کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10965227 | 1102739 | 2014 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Implementation of QbD for the development of a vaccine candidate
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موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
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چکیده انگلیسی
This case study provides an example of how Quality by Design (QbD) principles were applied to accelerate process development to manufacture a vaccine candidate at commercial scale. By leveraging an existing manufacturing platform process, a risk assessment was used to differentiate process parameters that could be defined using a combination of scientific and historical manufacturing knowledge from those that merited additional process characterization by experimentation. Select parameters, and their interactions, were evaluated by a Design of Experiment (DoE) series. This systematic approach required less time and fewer resources and resulted in the definition of a reliable and robust manufacturing process that meets regulatory requirements.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 32, Issue 24, 19 May 2014, Pages 2927-2930
Journal: Vaccine - Volume 32, Issue 24, 19 May 2014, Pages 2927-2930
نویسندگان
Jennifer Haas, Andrew Franklin, Matthew Houser, David Maraldo, Mark Mikola, Roberto Ortiz, Elizabeth Sullivan, José M. Otero,