کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8514830 | 1556512 | 2016 | 11 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Accelerating Vaccine Formulation Development Using Design of Experiment Stability Studies
ترجمه فارسی عنوان
توسعه سریع واکسن با استفاده از طراحی مطالعات پایداری آزمایشی
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کلمات کلیدی
Trizma baseWFIPBSDOEAlPO4menBOMVTRISDSC4-methylumbelliferyl phosphate - 4-methylumbelliferyl فسفاتlipooligosaccharide - lipopoligosaccharideLos - اینBiotechnology - بیوتکنولوژیAnalytical biochemistry - بیوشیمی تحلیلیEnzyme-linked immunosorbent assay - تست الیزاELISA - تست الیزاStability - ثباتdesign of experiment - طراحی آزمایشExcipients - عضلاتOuter membrane vesicles - غشای بیرونی vesiclesPhosphate-buffered saline - محلول نمک فسفات با خاصیت بافریVaccine adjuvants - مکمل های واکسنNADA - هیچ چیزVaccines - واکسنDifferential scanning calorimetry - کالریمتری روبشی افتراقی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
Vaccine drug product thermal stability often depends on formulation input factors and how they interact. Scientific understanding and professional experience typically allows vaccine formulators to accurately predict the thermal stability output based on formulation input factors such as pH, ionic strength, and excipients. Thermal stability predictions, however, are not enough for regulators. Stability claims must be supported by experimental data. The Quality by Design approach of Design of Experiment (DoE) is well suited to describe formulation outputs such as thermal stability in terms of formulation input factors. A DoE approach particularly at elevated temperatures that induce accelerated degradation can provide empirical understanding of how vaccine formulation input factors and interactions affect vaccine stability output performance. This is possible even when clear scientific understanding of particular formulation stability mechanisms are lacking. A DoE approach was used in an accelerated 37°C stability study of an aluminum adjuvant Neisseria meningitidis serogroup B vaccine. Formulation stability differences were identified after only 15 days into the study. We believe this study demonstrates the power of combining DoE methodology with accelerated stress stability studies to accelerate and improve vaccine formulation development programs particularly during the preformulation stage.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 10, October 2016, Pages 3046-3056
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 10, October 2016, Pages 3046-3056
نویسندگان
Patrick L. Ahl, Christopher Mensch, Binghua Hu, Heidi Pixley, Lan Zhang, Lance Dieter, Ryann Russell, William J. Smith, Craig Przysiecki, Mike Kosinski, Jeffrey T. Blue,