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.

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.

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.

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.

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.

Description based on publisher supplied metadata and other sources.

Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2022. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.