Lyophilized biologics and vaccines : modality-based approaches /: modality-based approaches. (2015)

• Record Type: Book
• Further Information: Note: Dushyant Varshney, Manmohan Singh, editors.
• Editors: Varshney, Dushyant; Manmohan Singh, 1964 November 8
• Contents: 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.
• Publisher Details: New York, NY : Springer
• Publication Date: 2015
• Extent: 1 online resource (xi, 401 pages), illustrations (some color)
• Subjects: 615.1/9; Medicine; Freeze-drying; Frozen drugs; MEDICAL -- Pharmacology; Freeze-drying; Frozen drugs; Freeze Drying -- methods; Biomedicine; Vaccine; Antibodies; Pharmaceutical Sciences/Technology; Medical -- Immunology; Medical -- Pharmacy; Immunology; Pharmaceutical technology; Vaccines; Monoclonal antibodies; Pharmaceutical technology; Electronic books
• Languages: English
• ISBNs: 9781493923830; 1493923838; 9781493923823
• Related ISBNs: 149392382X; 9781493923823
• Notes: Note: Online resource; title from PDF title page (SpringerLink, viewed May 27, 2015).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.