Optimization of Spray Drying Conditions for Yield, Particle Size and Biological Activity of Thermally Stable Viral Vectors

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• 作者：Daniel A. LeClair ; Emily D. Cranston ; Zhou Xing…
• 关键词：KEY WORDSadenovirus ; optimization ; particle size ; process parameters ; spray dry ; surface response methodology ; titre ; viral vector ; yield
• 刊名：Pharmaceutical Research
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：33
• 期：11
• 页码：2763-2776
• 全文大小：2,290 KB
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  Pharmacy
  Biochemistry
  Medical Law
  Biomedical Engineering
  
• 出版者：Springer Netherlands
• ISSN：1573-904X
• 卷排序：33

文摘

PurposeThis work examines the relevance of viral activity in the optimization of spray drying process parameters for the development of thermally stable vaccine powders. In some instances, the actual active pharmaceutical ingredient (API) is not included in the process optimization as it is deemed too costly to use until the final selection of operating conditions, however, that approach is inappropriate for highly labile biopharmaceutics. We investigate the effects of spray drying parameters on i) yield, ii) particle size and iii) viral vector activity of a mannitol/dextran encapsulated recombinant human type 5 adenoviral vector vaccine, to demonstrate the effects and magnitude of each effect on the three responses, and further show that the API must be included earlier in the optimization.