Nanocarrier Vaccines
Biopharmaceutics-Based Fast Track Development
1. Edition March 2024
528 Pages, Hardcover
Wiley & Sons Ltd
ISBN:
978-1-394-17468-3
John Wiley & Sons
Further versions
NANOCARRIER VACCINES
This book details the benefits, restrictions, and types of nanoparticles used in the creation of vaccines for the treatment and prevention of illnesses.
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.
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.
Preface xxi
Part 1 General 1
1 History of Nanoparticles 3
Keshava L. Jetha, Arya Vyas, Divya Teli, Amit Chaudhari, Riyansi Satasiya, Vishwa Patel, Shailvi Soni, Shail Modi and Vasso Apostolopoulos
1.1 Introduction 4
1.2 History of Nanoparticles 5
1.3 Modern Development of Nanoparticles 8
1.4 Type of Nanoparticles 10
1.5 Properties of Nanoparticles 13
1.6 Importance of Nanoparticles 15
1.7 Conclusion and Future Prospect 18
2 Composition of Nanoparticles 25
Amit Chaudhari, Palak Vadodariya, Arya Vyas, Disha Patel and Divya Teli
2.1 Introduction 25
2.2 Types of Nanoparticles 27
2.3 Composition of Nanoparticles 40
2.4 Synthesis of Nanoparticles 45
2.5 Nanoparticle Characterization by Various Instrumental Techniques 50
2.6 Understanding Nanotoxicity: Potential Risks and Implications 53
2.7 Conclusion 54
3 Nanotechnology and Vaccine Development 63
Keshava L. Jetha, Praful D. Bharadia and Manish P. Patel
3.1 Introduction 63
3.2 Overview of Vaccine Development 64
3.3 Advantages of Nanoparticles in Vaccine Delivery 66
3.4 Types of Nanoparticles as Vaccine Carriers 67
3.5 Development of Nanoparticle-Based Vaccine 70
3.6 Adjuvants and their Role in Vaccine Development 72
3.7 Nanoscale Adjuvants 74
3.8 Advantages 75
3.9 Techniques for Nanoscale Adjuvants 76
3.10 Route of Administration for Vaccines 77
3.11 Recent Advances in Nanotechnology-Based Vaccines 79
3.12 The Regulatory Perspective of Nanoparticle-Based Vaccine Development 80
3.13 Future Prospects 81
3.14 Conclusion 84
4 Nanoparticle Formulations: A Sustainable Approach to Biodegradable and Non-Biodegradable Products 95
Amandeep Singh, Shreni Parikh, Nutan Sethi, Sachin Patel, Nrupal Modi and Kaushika Patel
4.1 Introduction 96
4.2 Types of Nanoparticles 96
4.3 Preparation of Nanoparticles 100
4.4 Factors Affecting Selection of Method 100
4.5 Polymers Used in NP Formulation 107
4.6 Nanoparticle Formulations Based on Biodegradable Polymers 107
4.7 Nanoparticle Formulations Based on Non-Biodegradable Polymers 115
4.8 Nanoparticle Formulations Based on Natural Polymers 118
4.9 Challenges in NPs from Laboratory to Industrial Scale-Up 121
4.10 Nanoparticle-Based Approved & Marketed Formulations 122
4.11 Future Aspects & Conclusion 122
5 Nanoparticle Properties: Size, Shape, Charge, Inertness, Efficacy, Morphology 153
Kajal P. Baviskar, Brijesh M. Shah, Anjali P. Bedse, Shilpa S. Raut, Suchita P. Dhamane and Dhara J. Dave
5.1 Introduction 154
5.2 Applications of Nanoparticle Formulations 155
5.3 Interaction with Cells 157
5.4 Properties of Nanoparticles 159
5.5 Role of Physicochemical Properties in Nanoparticle Toxicity 174
5.6 Conclusion 177
Part 2 Nanoparticles to Deliver Antigen 193
6 Viral Vector-Based Nanoparticles 195
Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Oishani Sengupta, Anand Sairam, Paridhi Soni, Mohit Joshi, Bhumi Bhalodiya and Raj V.
6.1 Introduction 196
6.2 Characteristics of Viral Vector-Based Nanoparticles 197
6.3 Applications 199
6.4 Novel Advancements in Applications of Viral Nanoparticles 225
6.5 Limitations and Prospects of Viral Vector-Based Nanoparticle Approach 233
6.6 Conclusion 234
7 Lipid-Based Nanoparticles 241
Sunny Shah, Hardik Madhu, Moinuddin Soniwala, Dhaval Mori, Amit Vyas, Advaita Chauhan and Bhupendra Prajapati
7.1 Introduction 242
7.2 Types of Lipid-Based Nanoparticles 243
7.3 Synthesis of Lipid-Based Nanoparticles 245
7.4 Characterization of Lipid Nanoparticles 251
7.5 Applications of Lipid-Based Nanoparticles in Vaccines 257
7.6 Challenges and Future Directions 261
7.7 Conclusion 267
8 Nanoparticle-Based mRNA Vaccines: Are We One Step Closer to Targeted Cancer Therapy? 275
Lakshmi Vineela Nalla, Siva Nageswararao Gajula and Vivek P. Chavda
8.1 Introduction 276
8.2 Use of mRNA in Vaccines: Advantages and Challenges 278
8.3 How Do mRNA Vaccines Work? 279
8.4 Nanocarriers for mRNA Delivery 281
8.5 Nanoparticle-Based mRNA Vaccines in Cancer Therapy 285
8.6 Clinical Trials 291
8.7 Conclusion 295
9 Protein Delivery by Nanoparticles 305
Harshita Gauraha, Ankita Bhadoriya, Rupesh K. Gautam and Dinesh Kumar Mishra
9.1 Introduction 305
9.2 Major Challenges in Protein Delivery 307
9.3 Nanotechnology 308
9.4 Nanoparticles 310
9.5 Methods of Preparation 317
9.6 Nanoformulations Available for Protein and Peptide Delivery 322
9.7 Clinical Trials and Market-Approved Nanoparticles 325
9.8 Characterization of Protein Nanoparticles 329
9.9 Applications of Protein Nanoparticles 331
9.10 Conclusion 336
9.11 Future Developments 337
Part 3 Route of Administration 345
10 Oral Vaccine Delivery: Current Status 347
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 348
10.2 Need for Oral Vaccines 349
10.3 Nanoparticles as an Oral Vaccine Delivery System 350
10.4 Advantages of Oral Nanovaccines 355
10.5 Drawbacks and Disadvantages of Oral Nanovaccines 355
10.6 Barriers in Oral Vaccines Delivery 356
10.7 Currently Licensed Oral Vaccines 357
10.8 Descriptions of Licensed Oral Vaccines 360
10.9 Conclusion and Future Prospect 361
11 Nanovaccines for Mucosal Immunity 367
Shashi Kiran Misra, Anupria Kapoor and Kamla Pathak
11.1 Introduction 368
11.2 Mucosal Immunity 372
11.3 Nanovaccine Formulations 375
11.4 Future Perspectives 393
11.5 Conclusion 396
12 Nanovaccine via Intramuscular, Subcutaneous, and Intradermal Routes 405
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 406
12.3 Introduction to the Route of Administration 409
12.4 Comparable Adaptive Immune Response After IM, SC, and ID Routes 415
12.5 Marketed Formulation 416
12.6 Challenges of Vaccine Delivery 417
12.7 Conclusion 418
Part 4 Application and Advances 423
13 Nanovaccines for Veterinary Applications 425
Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Swati Punetha, Nikita Sharma, Sathvika Kamaraj and Raj V.
13.1 Introduction 426
13.2 Nanovaccines and Immune Response 431
13.3 Vaccine Production 433
13.4 Veterinary Applications of Nanovaccines 435
13.5 Comparative Analysis of Animal Vaccines, Nanovaccines, and Edible Vaccines 439
13.6 Regulation of Vaccine Production Process 441
13.7 New Approaches 450
13.8 Applications of Different Polymer-Based Nanoparticles 451
13.9 Future Prospects 453
13.10 Conclusion 454
14 Regulatory Pathways for Nanocarrier Vaccine 465
Niva Rani Gogoi, Rajashri Bezbaruah, Vishwa Patel, Riyansi Satasia, Bedanta Bhattacharjee and Bhaskar Mazumder
14.1 Introduction 466
14.2 The Need for a Regulatory Framework 467
14.3 Regulatory Requirements for the Manufacturing of NVs 469
14.4 Clinically Approved Nanocarrier Vaccines 470
14.5 Regulatory Challenges 474
14.6 Global Strategies for Clinical Approval 476
14.7 Conclusion and Future Prospects 479
References 479
Index 487
Part 1 General 1
1 History of Nanoparticles 3
Keshava L. Jetha, Arya Vyas, Divya Teli, Amit Chaudhari, Riyansi Satasiya, Vishwa Patel, Shailvi Soni, Shail Modi and Vasso Apostolopoulos
1.1 Introduction 4
1.2 History of Nanoparticles 5
1.3 Modern Development of Nanoparticles 8
1.4 Type of Nanoparticles 10
1.5 Properties of Nanoparticles 13
1.6 Importance of Nanoparticles 15
1.7 Conclusion and Future Prospect 18
2 Composition of Nanoparticles 25
Amit Chaudhari, Palak Vadodariya, Arya Vyas, Disha Patel and Divya Teli
2.1 Introduction 25
2.2 Types of Nanoparticles 27
2.3 Composition of Nanoparticles 40
2.4 Synthesis of Nanoparticles 45
2.5 Nanoparticle Characterization by Various Instrumental Techniques 50
2.6 Understanding Nanotoxicity: Potential Risks and Implications 53
2.7 Conclusion 54
3 Nanotechnology and Vaccine Development 63
Keshava L. Jetha, Praful D. Bharadia and Manish P. Patel
3.1 Introduction 63
3.2 Overview of Vaccine Development 64
3.3 Advantages of Nanoparticles in Vaccine Delivery 66
3.4 Types of Nanoparticles as Vaccine Carriers 67
3.5 Development of Nanoparticle-Based Vaccine 70
3.6 Adjuvants and their Role in Vaccine Development 72
3.7 Nanoscale Adjuvants 74
3.8 Advantages 75
3.9 Techniques for Nanoscale Adjuvants 76
3.10 Route of Administration for Vaccines 77
3.11 Recent Advances in Nanotechnology-Based Vaccines 79
3.12 The Regulatory Perspective of Nanoparticle-Based Vaccine Development 80
3.13 Future Prospects 81
3.14 Conclusion 84
4 Nanoparticle Formulations: A Sustainable Approach to Biodegradable and Non-Biodegradable Products 95
Amandeep Singh, Shreni Parikh, Nutan Sethi, Sachin Patel, Nrupal Modi and Kaushika Patel
4.1 Introduction 96
4.2 Types of Nanoparticles 96
4.3 Preparation of Nanoparticles 100
4.4 Factors Affecting Selection of Method 100
4.5 Polymers Used in NP Formulation 107
4.6 Nanoparticle Formulations Based on Biodegradable Polymers 107
4.7 Nanoparticle Formulations Based on Non-Biodegradable Polymers 115
4.8 Nanoparticle Formulations Based on Natural Polymers 118
4.9 Challenges in NPs from Laboratory to Industrial Scale-Up 121
4.10 Nanoparticle-Based Approved & Marketed Formulations 122
4.11 Future Aspects & Conclusion 122
5 Nanoparticle Properties: Size, Shape, Charge, Inertness, Efficacy, Morphology 153
Kajal P. Baviskar, Brijesh M. Shah, Anjali P. Bedse, Shilpa S. Raut, Suchita P. Dhamane and Dhara J. Dave
5.1 Introduction 154
5.2 Applications of Nanoparticle Formulations 155
5.3 Interaction with Cells 157
5.4 Properties of Nanoparticles 159
5.5 Role of Physicochemical Properties in Nanoparticle Toxicity 174
5.6 Conclusion 177
Part 2 Nanoparticles to Deliver Antigen 193
6 Viral Vector-Based Nanoparticles 195
Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Oishani Sengupta, Anand Sairam, Paridhi Soni, Mohit Joshi, Bhumi Bhalodiya and Raj V.
6.1 Introduction 196
6.2 Characteristics of Viral Vector-Based Nanoparticles 197
6.3 Applications 199
6.4 Novel Advancements in Applications of Viral Nanoparticles 225
6.5 Limitations and Prospects of Viral Vector-Based Nanoparticle Approach 233
6.6 Conclusion 234
7 Lipid-Based Nanoparticles 241
Sunny Shah, Hardik Madhu, Moinuddin Soniwala, Dhaval Mori, Amit Vyas, Advaita Chauhan and Bhupendra Prajapati
7.1 Introduction 242
7.2 Types of Lipid-Based Nanoparticles 243
7.3 Synthesis of Lipid-Based Nanoparticles 245
7.4 Characterization of Lipid Nanoparticles 251
7.5 Applications of Lipid-Based Nanoparticles in Vaccines 257
7.6 Challenges and Future Directions 261
7.7 Conclusion 267
8 Nanoparticle-Based mRNA Vaccines: Are We One Step Closer to Targeted Cancer Therapy? 275
Lakshmi Vineela Nalla, Siva Nageswararao Gajula and Vivek P. Chavda
8.1 Introduction 276
8.2 Use of mRNA in Vaccines: Advantages and Challenges 278
8.3 How Do mRNA Vaccines Work? 279
8.4 Nanocarriers for mRNA Delivery 281
8.5 Nanoparticle-Based mRNA Vaccines in Cancer Therapy 285
8.6 Clinical Trials 291
8.7 Conclusion 295
9 Protein Delivery by Nanoparticles 305
Harshita Gauraha, Ankita Bhadoriya, Rupesh K. Gautam and Dinesh Kumar Mishra
9.1 Introduction 305
9.2 Major Challenges in Protein Delivery 307
9.3 Nanotechnology 308
9.4 Nanoparticles 310
9.5 Methods of Preparation 317
9.6 Nanoformulations Available for Protein and Peptide Delivery 322
9.7 Clinical Trials and Market-Approved Nanoparticles 325
9.8 Characterization of Protein Nanoparticles 329
9.9 Applications of Protein Nanoparticles 331
9.10 Conclusion 336
9.11 Future Developments 337
Part 3 Route of Administration 345
10 Oral Vaccine Delivery: Current Status 347
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 348
10.2 Need for Oral Vaccines 349
10.3 Nanoparticles as an Oral Vaccine Delivery System 350
10.4 Advantages of Oral Nanovaccines 355
10.5 Drawbacks and Disadvantages of Oral Nanovaccines 355
10.6 Barriers in Oral Vaccines Delivery 356
10.7 Currently Licensed Oral Vaccines 357
10.8 Descriptions of Licensed Oral Vaccines 360
10.9 Conclusion and Future Prospect 361
11 Nanovaccines for Mucosal Immunity 367
Shashi Kiran Misra, Anupria Kapoor and Kamla Pathak
11.1 Introduction 368
11.2 Mucosal Immunity 372
11.3 Nanovaccine Formulations 375
11.4 Future Perspectives 393
11.5 Conclusion 396
12 Nanovaccine via Intramuscular, Subcutaneous, and Intradermal Routes 405
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 406
12.3 Introduction to the Route of Administration 409
12.4 Comparable Adaptive Immune Response After IM, SC, and ID Routes 415
12.5 Marketed Formulation 416
12.6 Challenges of Vaccine Delivery 417
12.7 Conclusion 418
Part 4 Application and Advances 423
13 Nanovaccines for Veterinary Applications 425
Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Swati Punetha, Nikita Sharma, Sathvika Kamaraj and Raj V.
13.1 Introduction 426
13.2 Nanovaccines and Immune Response 431
13.3 Vaccine Production 433
13.4 Veterinary Applications of Nanovaccines 435
13.5 Comparative Analysis of Animal Vaccines, Nanovaccines, and Edible Vaccines 439
13.6 Regulation of Vaccine Production Process 441
13.7 New Approaches 450
13.8 Applications of Different Polymer-Based Nanoparticles 451
13.9 Future Prospects 453
13.10 Conclusion 454
14 Regulatory Pathways for Nanocarrier Vaccine 465
Niva Rani Gogoi, Rajashri Bezbaruah, Vishwa Patel, Riyansi Satasia, Bedanta Bhattacharjee and Bhaskar Mazumder
14.1 Introduction 466
14.2 The Need for a Regulatory Framework 467
14.3 Regulatory Requirements for the Manufacturing of NVs 469
14.4 Clinically Approved Nanocarrier Vaccines 470
14.5 Regulatory Challenges 474
14.6 Global Strategies for Clinical Approval 476
14.7 Conclusion and Future Prospects 479
References 479
Index 487
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.
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.
