Lyophilized biologics and vaccines =...
Varshney, Dushyant.

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  • Lyophilized biologics and vaccines = modality-based approaches /
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Lyophilized biologics and vaccines/ edited by Dushyant Varshney, Manmohan Singh.
    其他題名: modality-based approaches /
    其他作者: Varshney, Dushyant.
    出版者: New York, NY :Springer New York : : 2015.,
    面頁冊數: xi, 401 p. :ill., digital ;24 cm.
    內容註: Preface -- Part I -- Lyophilization History and Fundamentals -- History of Lyophilization -- Heterogeneity of protein environments in frozen solutions and in the dried state -- Advance understanding of buffer behavior during lyophilization -- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles -- New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation technology -- Part II -- Lyophilized Biologics and Vaccines -- Modality Considerations -- Lyophilized Biologics -- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design -- Advances in Process Analytical Technology in Freeze Drying -- Process Scale-up and Optimization of Lyophilized Vaccine Products -- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations -- Part III -- Advances in Alternate Drying -- Alternatives to Vial Lyophilization -- Spray Drying of Biopharmaceuticals -- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals -- Case Studies and Examples of Biopharmaceutical Modalities -- Processed by Bulk Crystallization or Bulk Freeze Drying -- Part IV -- Regulatory, Packaging and Technology Transfer Considerations -- Lyophilization of Biologics - An FDA Perspective -- Recent Trends in Lyophilized Delivery Devices and Packaging -- Lyophilization Technology Transfer towards Product Launch.
    Contained By: Springer eBooks
    標題: Freeze-drying. -
    電子資源: http://dx.doi.org/10.1007/978-1-4939-2383-0
    ISBN: 9781493923830 (electronic bk.)
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