Nanocarrier Vaccines

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.

• Preface xxiPart 1 General 11 History of Nanoparticles 3Keshava L. Jetha, Arya Vyas, Divya Teli, Amit Chaudhari, Riyansi Satasiya, Vishwa Patel, Shailvi Soni, Shail Modi and Vasso Apostolopoulos1.1 Introduction 41.2 History of Nanoparticles 51.3 Modern Development of Nanoparticles 81.4 Type of Nanoparticles 101.5 Properties of Nanoparticles 131.6 Importance of Nanoparticles 151.7 Conclusion and Future Prospect 182 Composition of Nanoparticles 25Amit Chaudhari, Palak Vadodariya, Arya Vyas, Disha Patel and Divya Teli2.1 Introduction 252.2 Types of Nanoparticles 272.3 Composition of Nanoparticles 402.4 Synthesis of Nanoparticles 452.5 Nanoparticle Characterization by Various Instrumental Techniques 502.6 Understanding Nanotoxicity: Potential Risks and Implications 532.7 Conclusion 543 Nanotechnology and Vaccine Development 63Keshava L. Jetha, Praful D. Bharadia and Manish P. Patel3.1 Introduction 633.2 Overview of Vaccine Development 643.3 Advantages of Nanoparticles in Vaccine Delivery 663.4 Types of Nanoparticles as Vaccine Carriers 673.5 Development of Nanoparticle-Based Vaccine 703.6 Adjuvants and their Role in Vaccine Development 723.7 Nanoscale Adjuvants 743.8 Advantages 753.9 Techniques for Nanoscale Adjuvants 763.10 Route of Administration for Vaccines 773.11 Recent Advances in Nanotechnology-Based Vaccines 793.12 The Regulatory Perspective of Nanoparticle-Based Vaccine Development 803.13 Future Prospects 813.14 Conclusion 844 Nanoparticle Formulations: A Sustainable Approach to Biodegradable and Non-Biodegradable Products 95Amandeep Singh, Shreni Parikh, Nutan Sethi, Sachin Patel, Nrupal Modi and Kaushika Patel4.1 Introduction 964.2 Types of Nanoparticles 964.3 Preparation of Nanoparticles 1004.4 Factors Affecting Selection of Method 1004.5 Polymers Used in NP Formulation 1074.6 Nanoparticle Formulations Based on Biodegradable Polymers 1074.7 Nanoparticle Formulations Based on Non-Biodegradable Polymers 1154.8 Nanoparticle Formulations Based on Natural Polymers 1184.9 Challenges in NPs from Laboratory to Industrial Scale-Up 1214.10 Nanoparticle-Based Approved & Marketed Formulations 1224.11 Future Aspects & Conclusion 1225 Nanoparticle Properties: Size, Shape, Charge, Inertness, Efficacy, Morphology 153Kajal P. Baviskar, Brijesh M. Shah, Anjali P. Bedse, Shilpa S. Raut, Suchita P. Dhamane and Dhara J. Dave5.1 Introduction 1545.2 Applications of Nanoparticle Formulations 1555.3 Interaction with Cells 1575.4 Properties of Nanoparticles 1595.5 Role of Physicochemical Properties in Nanoparticle Toxicity 1745.6 Conclusion 177Part 2 Nanoparticles to Deliver Antigen 1936 Viral Vector–Based Nanoparticles 195Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Oishani Sengupta, Anand Sairam, Paridhi Soni, Mohit Joshi, Bhumi Bhalodiya and Raj V.6.1 Introduction 1966.2 Characteristics of Viral Vector–Based Nanoparticles 1976.3 Applications 1996.4 Novel Advancements in Applications of Viral Nanoparticles 2256.5 Limitations and Prospects of Viral Vector–Based Nanoparticle Approach 2336.6 Conclusion 2347 Lipid-Based Nanoparticles 241Sunny Shah, Hardik Madhu, Moinuddin Soniwala, Dhaval Mori, Amit Vyas, Advaita Chauhan and Bhupendra Prajapati7.1 Introduction 2427.2 Types of Lipid-Based Nanoparticles 2437.3 Synthesis of Lipid-Based Nanoparticles 2457.4 Characterization of Lipid Nanoparticles 2517.5 Applications of Lipid-Based Nanoparticles in Vaccines 2577.6 Challenges and Future Directions 2617.7 Conclusion 2678 Nanoparticle-Based mRNA Vaccines: Are We One Step Closer to Targeted Cancer Therapy? 275Lakshmi Vineela Nalla, Siva Nageswararao Gajula and Vivek P. Chavda8.1 Introduction 2768.2 Use of mRNA in Vaccines: Advantages and Challenges 2788.3 How Do mRNA Vaccines Work? 2798.4 Nanocarriers for mRNA Delivery 2818.5 Nanoparticle-Based mRNA Vaccines in Cancer Therapy 2858.6 Clinical Trials 2918.7 Conclusion 2959 Protein Delivery by Nanoparticles 305Harshita Gauraha, Ankita Bhadoriya, Rupesh K. Gautam and Dinesh Kumar Mishra9.1 Introduction 3059.2 Major Challenges in Protein Delivery 3079.3 Nanotechnology 3089.4 Nanoparticles 3109.5 Methods of Preparation 3179.6 Nanoformulations Available for Protein and Peptide Delivery 3229.7 Clinical Trials and Market-Approved Nanoparticles 3259.8 Characterization of Protein Nanoparticles 3299.9 Applications of Protein Nanoparticles 3319.10 Conclusion 3369.11 Future Developments 337Part 3 Route of Administration 34510 Oral Vaccine Delivery: Current Status 347Pankti C. Balar, Vidhi A. Modh, Sanjay P. Chauhan, Hetvi K. Solanki, Rajeshkumar K. Patel, Dasharath M. Patel and Maharshi B. Padya10.1 Introduction 34810.2 Need for Oral Vaccines 34910.3 Nanoparticles as an Oral Vaccine Delivery System 35010.4 Advantages of Oral Nanovaccines 35510.5 Drawbacks and Disadvantages of Oral Nanovaccines 35510.6 Barriers in Oral Vaccines Delivery 35610.7 Currently Licensed Oral Vaccines 35710.8 Descriptions of Licensed Oral Vaccines 36010.9 Conclusion and Future Prospect 36111 Nanovaccines for Mucosal Immunity 367Shashi Kiran Misra, Anupria Kapoor and Kamla Pathak11.1 Introduction 36811.2 Mucosal Immunity 37211.3 Nanovaccine Formulations 37511.4 Future Perspectives 39311.5 Conclusion 39612 Nanovaccine via Intramuscular, Subcutaneous, and Intradermal Routes 405Dixa 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. Raval12.1 Introduction 40612.3 Introduction to the Route of Administration 40912.4 Comparable Adaptive Immune Response After IM, SC, and ID Routes 41512.5 Marketed Formulation 41612.6 Challenges of Vaccine Delivery 41712.7 Conclusion 418Part 4 Application and Advances 42313 Nanovaccines for Veterinary Applications 425Suneetha Vuppu, Vivek P. Chavda, Toshika Mishra, Swati Punetha, Nikita Sharma, Sathvika Kamaraj and Raj V.13.1 Introduction 42613.2 Nanovaccines and Immune Response 43113.3 Vaccine Production 43313.4 Veterinary Applications of Nanovaccines 43513.5 Comparative Analysis of Animal Vaccines, Nanovaccines, and Edible Vaccines 43913.6 Regulation of Vaccine Production Process 44113.7 New Approaches 45013.8 Applications of Different Polymer-Based Nanoparticles 45113.9 Future Prospects 45313.10 Conclusion 45414 Regulatory Pathways for Nanocarrier Vaccine 465Niva Rani Gogoi, Rajashri Bezbaruah, Vishwa Patel, Riyansi Satasia, Bedanta Bhattacharjee and Bhaskar Mazumder14.1 Introduction 46614.2 The Need for a Regulatory Framework 46714.3 Regulatory Requirements for the Manufacturing of NVs 46914.4 Clinically Approved Nanocarrier Vaccines 47014.5 Regulatory Challenges 47414.6 Global Strategies for Clinical Approval 47614.7 Conclusion and Future Prospects 479References 479Index 487