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Nanocarrier Vaccines

Biopharmaceutics-Based Fast Track Development

Edited by Vivek Chavda and Vasso Apostolopoulos
Copyright: 2024   |   Status: Published
ISBN: 9781394174683  |  Hardcover  |  
516 pages

One Line Description
This book details the benefits, restrictions, and types of nanoparticles used in the creation of vaccines for the treatment and prevention of illnesses.

Audience
Researchers and pharmacy students in biomedical engineering and chemical engineering, biotechnology, as well as pharmaceutical and biopharmaceutical industry engineers working in drug discovery, chemical biology, computational chemistry, medicinal chemistry, and bioinformatics.

Description
In nanomedicine and nano-delivery systems, materials in the nanoscale range are used as diagnostic instruments or to administer therapeutic compounds to particular targeted regions in a controlled manner. By delivering precise medications to specified locations and targets, nanotechnology provides several advantages in treating chronic human illnesses. The use of nanomedicine (including chemotherapeutic medicines, biological agents, immunotherapeutic agents, etc.) in the treatment of various diseases has recently seen many notable applications. This book aims to be a single source material for understanding all the current and novel advancements in the field of nanotechnology.
In this groundbreaking book the reader will find:
• biodegradable and non-biodegradable formulations and properties such as size, shape, charge, inertness, efficacy, morphology, and more;
• show how different nanoparticles, such as lipid-based, viral vector-based, and metal, uphold very significant properties individually, suggesting applicability in various management tactics;
• examines how genetic information-carrying entities are becoming the norm for eradicating some diseases;
• gathers an exhaustive amount of information on routes of administration such as the oral route, mucosal immunity, intramuscular, subcutaneous, and intradermal;
• explores the legal regulations for nanotechnology-based approaches.

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Author / Editor Details
Vivek P. Chavda is an assistant professor in the Department of Pharmaceutics and Pharmaceutical Technology, L M College of Pharmacy, Ahmedabad, India. He is BPharm and MPharm Gold medalist at Gujarat Technological University. Before joining academia, he served as an R & D scientist in the biologics industry for almost 8 years with many successful regulatory filings. He has more than 150 national and international publications, 25 book chapters, and one patent in the pipeline. His research interests include the development of biologics processes and medical device development, nano-diagnostics, and non-carrier formulations, long-acting parenteral formulations, and nano-vaccines.

Professor Vasso Apostolopoulos is the Pro Vice-Chancellor, Research Partnerships at Victoria University, Australia. She received her PhD majoring in immunology in 1995 from the University of Melbourne, and the Advanced Certificate in Protein Crystallography from Birkbeck College, University of London. In response to the Covid-19 global emergency, Vasso and her team in VU’s immunology and translational research focused their efforts on investigating and working on vaccines and drugs to treat the virus. Professor Vasso Apostolopoulos is a world-renowned researcher who has been recognized with over 100 awards for the outstanding results of her research. She has more than 450 international publications to her credit.

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Table of Contents
Preface
Part 1 General
1. History of Nanoparticles

Keshava L. Jetha, Arya Vyas, Divya Teli, Amit Chaudhari, Riyansi Satasiya, Vishwa Patel, Shailvi Soni, Shail Modi and Vasso Apostolopoulos
1.1 Introduction
1.2 History of Nanoparticles
1.3 Modern Development of Nanoparticles
1.4 Type of Nanoparticles
1.5 Properties of Nanoparticles
1.5.1 Size
1.5.2 Shape
1.5.3 Surface Area
1.6 Importance of Nanoparticles
1.7 Conclusion and Future Prospect
References
2. Composition of Nanoparticles
Amit Chaudhari, Palak Vadodariya, Arya Vyas, Disha Patel and Divya Teli
2.1 Introduction
2.2 Types of Nanoparticles
2.2.1 Polymeric Nanoparticles
2.2.1.1 Polymeric Micelles
2.2.1.2 Dendrimer
2.2.1.3 Nanosphere
2.2.1.4 Nanocapsule
2.2.1.5 Polymersome
2.2.1.6 Nanocomplex
2.2.1.7 Nanogel
2.2.2 Inorganic Nanoparticle
2.2.2.1 Gold Nanoparticle
2.2.2.2 Silica Nanoparticle
2.2.2.3 Magnetic Nanoparticle
2.2.2.4 Quantum Dots
2.2.2.5 Nanocarbon
2.2.3 Hybrid Nanoparticle
2.2.3.1 Cell Membrane Coated Nanoparticle
2.2.3.2 Lipid Polymer Nanoparticle
2.2.3.3 Organic–Inorganic Nanocomposite
2.2.4 Bioinspired Nanoparticle
2.2.4.1 Exosomes
2.2.4.2 Protein Nanoparticle
2.2.4.3 DNA Nanostructure
2.2.5 Lipid-Based Nanoparticle
2.2.5.1 Liposome
2.2.5.2 Lipoplex
2.2.5.3 Solid Lipid Nanoparticle
2.3 Composition of Nanoparticles
2.3.1 Chitosan
2.3.2 Albumin
2.3.3 Polylactic Acid
2.3.4 Polylactide-co-glycolide (PLGA)
2.3.5 Polyacrylate
2.4 Synthesis of Nanoparticles
2.4.1 Top–Down Approach
2.4.1.1 Ball Milling
2.4.1.2 Physical Vapor Deposition (PVD)
2.4.1.3 Melt Mixing
2.4.1.4 Pulse Laser Ablation
2.4.2 Bottom-Up Approach
2.4.2.1 Chemical Vapor Deposition (CVD)
2.4.2.2 Thermal Decomposition Method
2.4.2.3 Chemical Methods
2.4.2.4 Biological Methods
2.5 Nanoparticle Characterization by Various Instrumental Techniques
2.5.1 Dynamic Light Scattering (DLS)
2.5.2 Zeta Potential
2.5.3 Microscopic Techniques to Characterize Nanoparticles
2.5.3.1 Scanning Electron Microscopy (SEM)
2.5.3.2 Transmission Electron Microscopy (TEM)
2.5.4 Spectroscopic Techniques to Characterize Nanoparticles
2.5.4.1 Ultraviolet-Visible Spectroscopy (UV-Vis)
2.5.4.2 Raman Spectroscopy
2.5.4.3 Fourier Transform Infrared Spectroscopy (FTIR)
2.5.5 X-Ray Diffraction Method (XRD)
2.6 Understanding Nanotoxicity: Potential Risks and Implications
2.7 Conclusion
References
3. Nanotechnology and Vaccine Development
Keshava L. Jetha, Praful D. Bharadia and Manish P. Patel
3.1 Introduction
3.2 Overview of Vaccine Development
3.3 Advantages of Nanoparticles in Vaccine Delivery
3.4 Types of Nanoparticles as Vaccine Carriers
3.4.1 Liposomes
3.4.2 Polymer-Based Nanoparticles
3.4.3 Virus-Like Particles (VLPs)
3.4.4 Nanogels
3.4.5 Inorganic Nanoparticles
3.5 Development of Nanoparticle-Based Vaccine
3.5.1 Viral Vector–Based Nanoparticle
3.5.2 Lipid-Based Nanoparticles
3.5.3 DNA-Based Nanoparticles
3.5.4 mRNA-Based Nanoparticles
3.5.5 Protein-Based Nanoparticles
3.6 Adjuvants and their Role in Vaccine Development
3.7 Nanoscale Adjuvants
3.8 Advantages
3.9 Techniques for Nanoscale Adjuvants
3.10 Route of Administration for Vaccines
3.11 Recent Advances in Nanotechnology-Based Vaccines
3.12 The Regulatory Perspective of Nanoparticle-Based Vaccine Development
3.13 Future Prospects
3.14 Conclusion
References
4. Nanoparticle Formulations: A Sustainable Approach to Biodegradable and Non-Biodegradable Products
Amandeep Singh, Shreni Parikh, Nutan Sethi, Sachin Patel, Nrupal Modi and Kaushika Patel
4.1 Introduction
4.2 Types of Nanoparticles
4.3 Preparation of Nanoparticles
4.4 Factors Affecting Selection of Method
4.4.1 Pressure
4.4.2 Particle Shape and Size
4.4.3 Environment
4.4.4 Pore Size
4.4.5 Particular Method or Technique
4.4.6 Cost of Preparation
4.4.7 Proximity
4.4.8 Time
4.4.9 Other Variables
4.5 Polymers Used in NP Formulation
4.6 Nanoparticle Formulations Based on Biodegradable Polymers
4.7 Nanoparticle Formulations Based on Non-Biodegradable Polymers
4.8 Nanoparticle Formulations Based on Natural Polymers
4.9 Challenges in NPs from Laboratory to Industrial Scale-Up
4.10 Nanoparticle-Based Approved & Marketed Formulations
4.11 Future Aspects & Conclusion
References
5. Nanoparticle Properties: Size, Shape, Charge, Inertness, Efficacy, Morphology
Kajal P. Baviskar, Brijesh M. Shah, Anjali P. Bedse, Shilpa S. Raut, Suchita P. Dhamane and Dhara J. Dave
5.1 Introduction
5.2 Applications of Nanoparticle Formulations
5.3 Interaction with Cells
5.4 Properties of Nanoparticles
5.4.1 Classification of Nanoparticle Properties
5.4.1.1 Physicochemical Properties
5.4.1.2 Optical Properties
5.4.1.3 Magnetic Properties
5.4.1.4 Catalytic Properties
5.4.1.5 Mechanical Properties
5.4.2 Different Properties
5.4.2.1 Size
5.4.2.2 Shape
5.4.2.3 Charge
5.4.2.4 Inertness
5.4.2.5 Efficacy
5.4.2.6 Morphology
5.5 Role of Physicochemical Properties in Nanoparticle Toxicity
5.6 Conclusion
References
Part 2 Nanoparticles to Deliver Antigen
6. Viral Vector–Based Nanoparticles

Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Oishani Sengupta, Anand Sairam, Paridhi Soni, Mohit Joshi, Bhumi Bhalodiya and Raj V.
6.1 Introduction
6.2 Characteristics of Viral Vector–Based Nanoparticles
6.3 Applications
6.3.1 Viral Nanoparticles for Drug Delivery
6.3.1.1 Antimicrobial Therapies
6.3.1.2 Cardiovascular Therapies
6.3.2 Viral Nanoparticles for Imaging
6.3.2.1 Nanoparticles are Used in PET/SPECT Scans
6.3.2.2 Nanoparticles Used in Ultrasonic Tests
6.3.2.3 Nanoparticles Utilized in CT Scans
6.3.2.4 Nanoparticles Employed in MRI Biomedical Applications
6.3.2.5 Illustrations of Nanoparticles Utilized in Fluorescence-Based Biological Applications
6.3.3 Viral Nanoparticles for Immunotherapy
6.3.4 Viral Nanoparticles for Theranostic Applications
6.4 Novel Advancements in Applications of Viral Nanoparticles
6.5 Limitations and Prospects of Viral Vector–Based Nanoparticle Approach
6.6 Conclusion
Acknowledgment
References
7. Lipid-Based Nanoparticles
Sunny Shah, Hardik Madhu, Moinuddin Soniwala, Dhaval Mori, Amit Vyas, Advaita Chauhan and Bhupendra Prajapati
7.1 Introduction
7.2 Types of Lipid-Based Nanoparticles
7.2.1 Solid Lipid Nanoparticles (SLNs)
7.2.2 Nanostructured Lipid Carriers (NLCs)
7.3 Synthesis of Lipid-Based Nanoparticles
7.3.1 Introduction to Lipids
7.3.2 Methods for Formulating Lipid Nanoparticles
7.3.2.1 High-Pressure Homogenization
7.3.2.2 Solvent Emulsification–Evaporation
7.3.2.3 Microemulsion-Based Method
7.3.2.4 Hot-Melt Homogenization
7.3.2.5 Spray Drying
7.3.2.6 Solvent Injection Method
7.3.2.7 Microfludics
7.4 Characterization of Lipid Nanoparticles
7.4.1 Size and Shape
7.4.2 Surface Charge
7.4.2.1 Analytical Techniques for Surface Charge Characterization
7.4.2.2 Zeta Potential Measurement
7.4.2.3 Electrophoresis
7.4.2.4 Isoelectric Focusing
7.4.3 Encapsulation Efficiency
7.4.3.1 Factors Affecting Encapsulation Efficiency
7.4.3.2 Analytical Techniques for Encapsulation Efficiency Characterization
7.4.4 Stability
7.4.4.1 Factors Affecting Stability
7.4.4.2 Analytical Techniques for Stability Characterization
7.5 Applications of Lipid-Based Nanoparticles in Vaccines
7.5.1 Enhancement of Immune Response
7.5.2 Targeted Delivery
7.5.2.1 Cancer Immunotherapy
7.5.2.2 mRNA-Based Vaccines
7.5.2.3 Gene Therapy
7.5.3 Adjuvant Effects
7.5.3.1 mRNA COVID-19 Vaccines
7.5.3.2 Human Papillomavirus (HPV) Vaccine
7.5.3.3 Influenza Vaccine
7.6 Challenges and Future Directions
7.6.1 Safety and Toxicity Concerns
7.6.1.1 Preclinical Safety Evaluation
7.6.1.2 Human Pharmacology Studies
7.6.1.3 Postmarketing Surveillance
7.6.1.4 Adverse Event Reporting
7.6.2 Stability Issues
7.6.2.1 Formulation Optimization
7.6.2.2 Analytical Method Development
7.6.2.3 Accelerated Stability Studies
7.6.2.4 Quality by Design (QbD)
7.6.3 Scale-Up Production Challenges
7.6.3.1 Equipment Design
7.6.3.2 Process Optimization
7.6.3.3 Regulatory Compliance
7.6.4 Opportunities for Future Research
7.6.4.1 Novel Antigen and Adjuvant Formulations
7.6.4.2 Targeted Delivery
7.6.4.3 Manufacturing Process Optimization
7.6.4.4 Immunological Mechanisms
7.6.4.5 Opportunities for Future Research
7.7 Conclusion
References
8. Nanoparticle-Based mRNA Vaccines: Are We One Step Closer to Targeted Cancer Therapy?
Lakshmi Vineela Nalla, Siva Nageswararao Gajula and Vivek P. Chavda
8.1 Introduction
8.2 Use of mRNA in Vaccines: Advantages
and Challenges
8.3 How Do mRNA Vaccines Work?
8.4 Nanocarriers for mRNA Delivery
8.4.1 Liposomes and RNA Lipoplexes
8.4.2 Lipid Nanoparticles
8.4.3 Polymer-Based Nanoparticles
8.4.4 Hybrid Nanoparticles
8.5 Nanoparticle-Based mRNA Vaccines in Cancer Therapy
8.5.1 Breast Cancer
8.5.2 Colorectal Cancer
8.5.3 Lung Cancer
8.5.4 Glioma Tumor
8.5.5 Other Tumors
8.6 Clinical Trials
8.6.1 Considerations for Clinical Translation
8.7 Conclusion
References
9. Protein Delivery by Nanoparticles
Harshita Gauraha, Ankita Bhadoriya, Rupesh K. Gautam and Dinesh Kumar Mishra
9.1 Introduction
9.2 Major Challenges in Protein Delivery
9.3 Nanotechnology
9.4 Nanoparticles
9.4.1 Nanocarriers
9.4.2 Protein Nanocarrier
9.4.3 Protein and Its Type Used to Produce Protein Nanoparticles
9.4.3.1 Silk Protein Fibroin
9.4.3.2 Human Serum Albumin
9.4.3.3 Gliadin
9.4.3.4 Gelatin
9.4.3.5 Legumin
9.4.3.6 30Kc19 Protein Obtained from Silkworm Hemolymph
9.4.3.7 Ferritin
9.5 Methods of Preparation
9.5.1 Chemical Methods
9.5.1.1 Emulsion/Solvent Extraction
9.5.2 Physical Method
9.5.2.1 Nano Spray Drying
9.5.2.2 Electrospraying Technique
9.5.2.3 Self-Assembly
9.5.2.4 Desolvation
9.6 Nanoformulations Available for Protein and Peptide Delivery
9.6.1 Dendrimers
9.6.2 Liposomes
9.6.3 Solid Lipid Nanoparticles
9.6.4 Polymeric Nanoparticles
9.6.5 Polymeric Micelles
9.7 Clinical Trials and Market-Approved Nanoparticles
9.7.1 Nanomedicine and Proteins in the Field of Treatment and Diagnosis
9.8 Characterization of Protein Nanoparticles
9.8.1 Particle Size and Polydispersity
9.8.2 Particle Morphology
9.8.3 Particle Structure/Surface Charge
9.8.4 Drug Loading and Release
9.9 Applications of Protein Nanoparticles
9.9.1 Routes
9.9.1.1 Oral Route
9.9.1.2 Nasal and Pulmonary Route
9.9.1.3 Blood–Brain Barrier Route
9.9.1.4 Transdermal Delivery
9.9.2 Non-Viral Gene Therapy
9.9.3 Immunological Adjuvant
9.9.4 Antibiotics
9.9.5 Diseases
9.9.5.1 Tuberculosis (TB)
9.9.5.2 Cancer Therapy
9.9.5.3 Leishmaniasis
9.9.5.4 Rheumatoid Arthritis
9.10 Conclusion
9.11 Future Developments
References
Part 3 Route of Administration
10. Oral Vaccine Delivery: Current Status

Pankti C. Balar, Vidhi A. Modh, Sanjay P. Chauhan, Hetvi K. Solanki, Rajeshkumar K. Patel, Dasharath M. Patel and Maharshi B. Padya
10.1 Introduction
10.2 Need for Oral Vaccines
10.3 Nanoparticles as an Oral Vaccine Delivery System
10.3.1 Lipid Nanoparticles
10.3.2 Polymeric Nanoparticles
10.3.3 Vesicular Delivery
10.4 Advantages of Oral Nanovaccines
10.5 Drawbacks and Disadvantages of Oral Nanovaccines
10.6 Barriers in Oral Vaccines Delivery
10.6.1 Physiological Barrier
10.6.2 Immunological Barrier
10.7 Currently Licensed Oral Vaccines
10.8 Descriptions of Licensed Oral Vaccines
10.8.1 Oral Polio Vaccine
10.8.2 Live Oral Typhoid Vaccine
10.8.3 Cholera Vaccine
10.8.4 Rotavirus Vaccine
10.8.5 Oral Adenovirus Vaccine
10.9 Conclusion and Future Prospect
References
11. Nanovaccines for Mucosal Immunity
Shashi Kiran Misra, Anupria Kapoor and Kamla Pathak
11.1 Introduction
11.2 Mucosal Immunity
11.3 Nanovaccine Formulations
11.3.1 Polymer-Based Nanovaccines
11.3.1.1 Polylactide-co-Glycolide (PLGA)-Based Mucosal Nanovaccines
11.3.1.2 Chitosan-Based Mucosal Nanovaccines
11.3.1.3 Alginate-Based Mucosal Vaccines
11.3.1.4 Beta Glucan-Based Mucosal Vaccines
11.3.1.5 Poly-(ε-Caprolactone)/Chitosan-Based Mucosal Vaccines
11.3.2 Carbon Nanotube-Based Mucosal Vaccines
11.3.3 Inorganic Nanoparticle-Based Mucosal Vaccines
11.3.3.1 Silica-Based Nanoparticles
11.3.3.2 Gold Nanoparticles (AuNPs)
11.3.4 Virus-Like Particles (VLP)-Based Mucosal Vaccines
11.4 Future Perspectives
11.5 Conclusion
References
12. Nanovaccine via Intramuscular, Subcutaneous, and Intradermal Routes
Dixa A. Vaghela, Maharshi Bhailalbhai Pandya, Pooja M. Parmar, Sanjay P. Chauhan, Akta Vaishnav, Rajeshkumar K. Patel, Dasharath M. Patel, Vidhi Ankit Modh and Mihir K. Raval
12.1 Introduction
12.1.1 What is a Nanovaccine?
12.2 History of Nanovaccination
12.3 Introduction to the Route of Administration
12.3.1 Intramuscular
12.3.2 Subcutaneous
12.3.3 Intradermal
12.4 Comparable Adaptive Immune Response After IM, SC, and ID Routes
12.5 Marketed Formulation
12.6 Challenges of Vaccine Delivery
12.7 Conclusion
Acknowledgment
References
Part 4 Application and Advances
13. Nanovaccines for Veterinary Applications

Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Swati Punetha, Nikita Sharma, Sathvika Kamaraj and Raj V.
13.1 Introduction
13.1.1 Diverse Types of Nanovaccines in the Veterinary Field
13.1.1.1 Polymeric Nanoparticles
13.1.1.2 Liposomes
13.1.1.3 Fullerenes and Bucky Tubes
13.1.1.4 Microbivores and Respirocytes
13.1.1.5 Nanoshells
13.1.1.6 Quantum Dots
13.1.1.7 Solid Lipid Nanoparticles
13.1.1.8 Magnetic Iron Oxide Nanoparticles
13.1.1.9 Dendrimers
13.1.1.10 Nanoemulsions
13.1.1.11 Nanobubbles
13.1.1.12 Aluminosilicate Nanoparticles
13.1.1.13 Polymeric Micelles
13.1.1.14 Polymer-Coated Nanocrystals
13.1.1.15 Polymeric Nanospheres
13.1.1.16 Metallic Nanoparticles
13.2 Nanovaccines and Immune Response
13.3 Vaccine Production
13.4 Veterinary Applications of Nanovaccines
13.4.1 Disease Prevention in Cattle
13.4.1.1 Viral Diseases
13.4.1.2 Bacterial Diseases
13.5 Comparative Analysis of Animal Vaccines, Nanovaccines, and Edible Vaccines
13.6 Regulation of Vaccine Production Process
13.7 New Approaches
13.8 Applications of Different Polymer-Based Nanoparticles
13.9 Future Prospects
13.10 Conclusion
Acknowledgments
References
14. Regulatory Pathways for Nanocarrier Vaccine
Niva Rani Gogoi, Rajashri Bezbaruah, Vishwa Patel, Riyansi Satasia, Bedanta Bhattacharjee and Bhaskar Mazumder
14.1 Introduction
14.2 The Need for a Regulatory Framework
14.3 Regulatory Requirements for the Manufacturing of NVs
14.3.1 Upstream Manufacturing Process
14.3.2 Downstream Manufacturing Process
14.4 Clinically Approved Nanocarrier Vaccines
14.5 Regulatory Challenges
14.5.1 Existing Regulatory Guidelines are not Adequate for the Regulation of Nanocarrier Vaccines
14.5.2 Lack of an Appropriate Risk Governance Organization
14.5.3 No Act is Nanovaccine-Specific Framed
14.5.4 Lack of Proper Regulatory Framework for Patentability
14.6 Global Strategies for Clinical Approval
14.6.1 The United States of America
14.6.2 The European Union
14.6.3 The United Kingdom
14.6.4 Canada
14.6.5 Japan
14.6.6 Other Countries
14.7 Conclusion and Future Prospects
References
Index

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