Practical Aspects of Vaccine Development. (Record no. 36169)

MARC details
000 -LEADER
fixed length control field 10514nam a22004453i 4500
001 - CONTROL NUMBER
control field EBC6724552
003 - CONTROL NUMBER IDENTIFIER
control field MiAaPQ
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20220524154604.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m o d |
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cnu||||||||
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 220504s2021 xx o ||||0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9780128143582
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9780128143575
035 ## - SYSTEM CONTROL NUMBER
System control number (MiAaPQ)EBC6724552
035 ## - SYSTEM CONTROL NUMBER
System control number (Au-PeEL)EBL6724552
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)1273973335
040 ## - CATALOGING SOURCE
Original cataloging agency MiAaPQ
Language of cataloging eng
Description conventions rda
-- pn
Transcribing agency MiAaPQ
Modifying agency MiAaPQ
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Kolhe, Parag.
245 10 - TITLE STATEMENT
Title Practical Aspects of Vaccine Development.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture San Diego :
Name of producer, publisher, distributor, manufacturer Elsevier Science & Technology,
Date of production, publication, distribution, manufacture, or copyright notice 2021.
264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Date of production, publication, distribution, manufacture, or copyright notice �2022.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (388 pages)
336 ## - CONTENT TYPE
Content type term text
Content type code txt
Source rdacontent
337 ## - MEDIA TYPE
Media type term computer
Media type code c
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term online resource
Carrier type code cr
Source rdacarrier
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Front Cover -- Practical Aspects of Vaccine Development -- Practical Aspects of Vaccine Development -- Copyright -- Contents -- Contributors -- Preface -- Acknowledgments -- 1 - Introduction to vaccine development -- Vaccines: the greatest advancement of modern medicine -- A brief historical review -- The foundation of vaccine development -- A summary of current strategies in vaccine development -- Adjuvants -- Summary -- References -- 2 - Overview of vaccine adjuvants -- Introduction -- General classification of vaccine adjuvants -- Specific types of adjuvants -- Aluminum salts -- Emulsion adjuvants -- Lipid-based adjuvants -- Immune potentiators -- Combination adjuvants -- Future considerations in the development of adjuvants -- Conclusions -- Trademark statement -- References -- 3 - Formulation design considerations and good practice for live attenuated vaccine development -- Introduction -- Live-attenuated vaccines -- Development of products with the end in mind -- The product target product profile -- The product quality target product profile -- Product critical quality attributes -- Analytics for formulation -- Stability assessment and temperature selection -- Development by design -- Excipient options -- Excipient considerations -- Rational design of formulations for live-attenuated vaccines -- A quality by design formulation development approach -- A sequential quality-by-design approach to formulation development -- Scoping studies -- Screening studies -- Categorical excipient choices for vaccine-excipient compatibility in prototype formulation selection -- Excipient concentration ranges and other process and device parameters -- Optimization of concentrations, processes and devices using response surface method study designs -- Central composite design -- Box-Behnken design.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Screening and optimization of formulations only (mixture designs) -- Optimal or custom designs -- Definitive screening designs -- Postoptimization: model validation, verification, and confirmation -- Predicted design and control space selection and quality risk assessment using graphical and numerical optimization -- Predicted design and control space selection and quality risk assessments using simulation and soft tools -- Formulation and process validation (robustness designs) -- Summary -- References -- 4 - Subunit-based vaccines: challenges in developing protein-based vaccines -- Introduction -- Similarities of vaccine proteins to therapeutic proteins -- Pneumococcal protein-based vaccine development -- Pneumococcal virulence factors -- Licensed pneumococcal vaccines -- Recombinant pneumococcal proteins as vaccine candidates -- Alternative approaches for pneumococcal vaccines -- Chlamydia trachomatis vaccine development -- Protective immunity against Chlamydia trachomatis -- Chlamydia trachomatis vaccine candidates -- Ricin vaccine development -- Ricin vaccine candidates -- Norovirus vaccine development -- NoV vaccine candidates -- Clostridium difficile vaccine development -- Clostridium difficile vaccine candidates -- Overarching problems in vaccine development -- Acknowledgments -- References -- 5 - QbD approach to formulation development for protein-based vaccines -- Scope and challenges of protein bases formulation development -- Quality by design as a guiding principle in vaccine formulation development -- Preformulation studies -- Formulation development and optimization studies -- Definition of appropriate dosage form -- Development of formulation composition -- Multicomponents vaccines formulation development -- Formulation optimization: formulation space definition -- Compatibility studies for reconstituted vaccines -- Conclusion.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Acknowledgments -- References -- 6 - pDNA and mRNA vaccines -- Introduction -- A brief history of vaccination -- Advantages of nucleic acid-based vaccination -- Harnessing and directing immune responses -- Production-speed and scale -- Native endogenous protein translation -- pDNA and mRNA vaccination -- a two-horse race? -- Basic biology of pDNA and mRNA vaccines -- Structure of pDNA vectors -- Structure of mRNA -- pDNA and mRNA pharmacology -- pDNA and mRNA vaccine immunogenicity -- Nucleic acid vaccine development -- DNA vaccines-how far from clinic? -- Delivery strategies -- Formulation approaches -- DNA vaccine clinical trials -- mRNA vaccines-delivering the messenger -- The challenges of in vivo delivery -- "Naked" mRNA vaccine delivery -- Nanoparticle delivery systems for mRNA -- Lipid nanoparticles for mRNA delivery -- Delivering mRNA ligand-based nanoparticle -- RNA vaccine clinical trials -- Process development -- scalability and manufacturability -- pDNA plasmid vaccine manufacture -- mRNA vaccine manufacture -- The future of nucleic acid vaccines -- The first responder to epidemic threats-a vaccine on-demand? -- Beyond viruses -- Beyond vaccination -- Concluding remarks -- References -- 7 - Antigen-adjuvant formulations-key considerations -- Introduction -- Considerations for antigen-adjuvant compatibility -- Aluminum adjuvant considerations -- Emulsion adjuvant considerations -- Lipid-based adjuvants -- Drug product design and considerations for dose preparation and administration -- Container closure -- Lyophilization of antigen-adjuvant formulation considerations -- Formulation considerations for lyophilization -- Vaccine antigens -- Antigen-adjuvant combinations (adjuvanted vaccines) -- Summary -- References -- 8 - Suspension properties and characterization of aluminum-adjuvanted vaccines -- Introduction.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Aluminum-containing adjuvant structure -- Principles of suspension behavior -- Theory of stability -- Controlled flocculation -- Properties and characterization -- Chemical composition and structure -- Particle size characterization -- Laser diffraction -- Flow imaging microscopy -- Sedimentation -- Sediment -- Microcomputed topography -- Surface charge -- Zeta-potential -- Point of zero charge -- Rheology -- Surface area -- Adsorption -- Spectroscopy -- Considerations in vaccine development -- Formulation -- Shear -- Redispersion -- Conclusion -- References -- 9 - Effect of shipping stresses on suspension vaccines -- Introduction -- Interplay between particle size, charge, and settling rate -- Effect of shipping stress on thermodynamic suspension stability -- Impact of individual shipping stresses on redispersion time -- Mitigation strategy to reduce high redispersion time -- Impact of shipping temperature on suspension vaccines -- Summary and recommendations -- References -- 10 - Control strategy development guide for vaccine drug product -- Introduction to control strategy approach -- Control strategy considerations -- How to develop control strategy -- Cause-and-effect matrix and risk assessment -- Application of control strategy concept -- Control strategy considerations -- Drug substance container -- Considerations for control at drug substance versus drug product site -- Control strategy construction through cause-and-effect matrix -- Amount of drug substance added to drug substance container -- Amount transferred from drug substance container to compounding tank -- Mixing speed and time for adjuvant and final bulk vaccine -- In-process controls and application of process analytical technology -- Process analytical technology application -- Raw material control strategy -- Control strategy for protein concentration.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note Constructing final control strategy -- Summary and considerations for control strategy -- References -- 11 - Lyophilized vaccine development -- Introduction -- Overview of lyophilization formulation and process -- Freezing -- Primary drying -- Secondary drying -- Vaccine-specific considerations -- Conjugates and multivalent conjugate vaccines -- Live-attenuated -- Subunit vaccines -- Inactivated vaccines -- Antigen adjuvant lyophilization -- Novel vaccine -- Considerations for lyophilization cycle scale-up -- Summary -- References -- 12 - Conventional and nontraditional delivery methods and routes of vaccine administration -- The choice: the importance of the correct delivery system for an effective vaccination -- Conventional delivery methods: subcutaneous and intramuscular route -- Intramuscular delivery system -- Subcutaneous delivery system -- Limits of the conventional delivery system -- Epidermis and dermis as new sites of vaccine delivery -- Permeabilization of the skin -- Abrasion -- Chemical enhancers -- Thermal ablation -- Sonophoresis -- Electroporation -- Jet injectors -- Microneedles -- Solid microneedles -- Coated microneedles -- Dissolving microneedles -- Hollow microneedles -- Hydrogel-forming microneedles -- Other areas of the body as targets for vaccine delivery -- Nasal mucosa delivery -- Oral mucosa delivery -- Conclusion -- References -- Index -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W -- X -- Z -- Back Cover.
588 ## - SOURCE OF DESCRIPTION NOTE
Source of description note Description based on publisher supplied metadata and other sources.
590 ## - LOCAL NOTE (RLIN)
Local note Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2022. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Ohtake, Satoshi.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Print version:
Main entry heading Kolhe, Parag
Title Practical Aspects of Vaccine Development
Place, publisher, and date of publication San Diego : Elsevier Science & Technology,c2021
International Standard Book Number 9780128143575
797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN)
Corporate name or jurisdiction name as entry element ProQuest (Firm)
850 ## - HOLDING INSTITUTION
Holding institution
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="https://ebookcentral.proquest.com/lib/vajira-ebooks/detail.action?docID=6724552">https://ebookcentral.proquest.com/lib/vajira-ebooks/detail.action?docID=6724552</a>
Public note Click to View
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme National Library of Medicine Classification
Koha item type Electronic books
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Total Checkouts Barcode Date last seen Price effective from Koha item type
    National Library of Medicine Classification   Online Access Kuakarun Nursing Library Kuakarun Nursing Library Processing unit 24/05/2022   eb36169 24/05/2022 24/05/2022 Electronic books