Subunit Vaccine Delivery PDF
Preview Subunit Vaccine Delivery
Advances in Delivery Science and Technology Camilla Foged Thomas Rades Yvonne Perrie Sarah Hook Editors Subunit Vaccine Delivery Advances in Delivery Science and Technology Series Editor Michael J. Rathbone More information about this series at h ttp://www.springer.com/series/8875 Camilla Foged (cid:129) Thomas Rades Yvonne Perrie (cid:129) Sarah Hook Editors Subunit Vaccine Delivery Editors Camilla Foged Thomas Rades Department of Pharmacy Department of Pharmacy Faculty of Health and Medical Sciences Faculty of Health and Medical Sciences University of Copenhagen University of Copenhagen Copenhagen , Denmark Copenhagen , Denmark Yvonne Perrie Sarah Hook Pharmacy School Division of Health Sciences School of Life and Health Sciences School of Pharmacy Aston University University of Otago Birmingham , UK Dunedin , New Zealand ISSN 2192-6204 ISSN 2192-6212 (electronic) ISBN 978-1-4939-1416-6 ISBN 978-1-4939-1417-3 (eBook) DOI 10.1007/978-1-4939-1417-3 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2014954730 © Springer Science+Business Media New York 2015 T his work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. T he use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Pref ace The objective of this book is to compile the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. The book’s goal is to provide a comprehensive overview of the scientifi c and regulatory challenges facing scientists who research and develop subunit vac- cines. The scope of the book is wide. It is written in a manner that will enlighten newcomers to the fi eld (e.g., Ph.D. students or experienced scientist switching fi elds) yet provides an in-depth knowledge that would benefi t a skilled worker in the fi eld. A signifi cant improvement in the safety of modern vaccines has been the develop- ment of subunit vaccines, as these are composed of very well-defi ned and highly pure components, often recombinant proteins. However, since protein-based anti- gens in general are weakly immunogenic by themselves, co-administration of adju- vants is required to induce potent and persistent specifi c immune responses. In recent years, there has been substantial progress in the discovery of new effi cient adjuvants for subunit vaccines that are often classifi ed into delivery systems (e.g., liposomes, emulsions, and polymeric nanoparticles) and immunopotentiating compounds that constitute pathogen-associated molecular patterns, such as the toll-like receptor ligands. The combination of delivery systems and immunopotentiators has created highly effi cacious adjuvants due to concomitant enhanced antigen delivery and potent stimulation of immunity. Many of these adjuvants are of a particulate nature and mimic the structure and/or composition of microbes in a reductionist fashion. Examples are liposomes, polymeric nanoparticles, emulsions, and virus- like parti- cles. However, there are a substantial number of pharmaceutical challenges associ- ated with the subunit vaccine development process due to the complex nature of the antigen–adjuvant combinations. These challenges will be presented and discussed in this book. Copenhagen, Denmark Camilla Foged Copenhagen, Denmark Thomas Rades Birmingham, UK Yvonne Perrie Dunedin, New Zealand Sarah Hook v Contents Part I Background 1 Immunological Background ................................................................... 3 Andrew J. Highton and Roslyn A. Kemp 2 Classification of Vaccines ....................................................................... 15 Rie S. Kallerup and Camilla Foged Part II Delivery Systems for Subunit Vaccines 3 Aluminum Adjuvants: Basic Concepts and Progress in Understanding ..................................................................................... 33 Erik B. Lindblad 4 Emulsions as Vaccine Adjuvants ........................................................... 59 Ruchi R. Shah , Luis A. Brito , Derek T. O’Hagan , and Mansoor M. Amiji 5 The Application of Liposomes as Vaccine Adjuvants .......................... 77 Elisabeth Kastner , Signe T. Schmidt , Alexander Wilkinson , Dennis Christensen , and Yvonne Perrie 6 Developing Bilayer-Based Delivery Systems for Oral Delivery of Subunit Vaccines ................................................................................. 95 Jitinder S. Wilkhu and Yvonne Perrie 7 Cubosomes: Structure, Preparation and Use as an Antigen Delivery System ....................................................................................... 125 Shakila B. Rizwan and Ben J. Boyd 8 ISCOMs as a Vaccine Delivery System ................................................. 141 Hanne M. Nielsen , Henriette B. Hübschmann , and Thomas Rades vii viii Contents 9 Virus-Like Particles, a Versatile Subunit Vaccine Platform ............... 159 Braeden Donaldson , Farah Al-Barwani , Vivienne Young , Sarah Scullion , Vernon Ward , and Sarah Young 10 Polymeric Particulates for Subunit Vaccine Delivery .......................... 181 Thomas Schuster , Martin Nussbaumer , P atric Baumann , Nico Bruns , Wolfgang Meier , and Anja Car 11 Gels as Vaccine Delivery Systems .......................................................... 203 Sarah Gordon 12 Implants as Sustained Release Delivery Devices for Vaccine Antigens ............................................................................... 221 Julia Engert 13 Dendritic Cell-Based Vaccines ............................................................... 243 Olivier Gasser and Ian F. Hermans Part III Delivery Routes, Devices and Dosage Forms 14 Parenteral Vaccine Administration: Tried and True ........................... 261 Pål Johansen and Thomas M. Kündig 15 Nasal Administration of Vaccines .......................................................... 287 Regina Scherließ 16 Pulmonary Administration of Subunit Vaccines .................................. 307 Wouter F. Tonnis , Anke L. W. Huckriede , Wouter L.J. Hinrichs , and Henderik W. Frijlink 17 Vaginal Delivery of Subunit Vaccines .................................................... 331 Deborah Lowry 18 Transcutaneous Immunization .............................................................. 347 Teerawan Rattanapak , Camilla Foged , and Sarah Hook Part IV Pharmaceutical Analysis and Quality Control of Vaccines 19 Pharmaceutical Analysis and Quality Control of Vaccines................. 373 Michele Pallaoro 20 The Physical Analysis of Vaccines ......................................................... 385 Yuan Cheng , Justin C. Thomas , Sangeeta B. Joshi , David B. Volkin , and C. Russell Middaugh 21 Characterizing the Association Between Antigens and Adjuvants ......................................................................................... 413 Mette Hamborg and Camilla Foged Index ................................................................................................................. 427 Contributors Farah Al-Barwani D epartment of Microbiology and Immunology, S chool of Medical Sciences, University of Otago , D unedin , New Zealand D epartment of Pathology, S chool of Medicine, University of Otago, D unedin, New Zealand Mansoor M. Amiji Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University , Boston , MA , USA Patric Baumann Department of Chemistry , University of Basel , Basel , Switzerland Ben J. Boyd Faculty of Pharmacy and Pharmaceutical Sciences , Monash University , Melbourne , VIC , Australia Luis A. Brito Novartis Vaccines & Diagnostics , Cambridge , MA , USA Nico Bruns Department of Chemistry , University of Basel , Basel , Switzerland Adolphe Merkle Institute, University of Fribourg , Marly , Switzerland Anja Car Department of Chemistry , University of Basel , Basel , Switzerland Yuan Cheng Department of Discovery Pharmaceutics, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Princeton, NJ, USA Dennis Christensen D epartment of Infectious Disease Immunology, V accine Adjuvant Research, Statens Serum Institut , Copenhagen , Denmark Braeden Donaldson Department of Microbiology and Immunology , School of Medical Sciences, University of Otago , D unedin , New Zealand D epartment of Pathology, S chool of Medicine, University of Otago, D unedin, New Zealand Julia Engert D epartment of Pharmacy, Pharmaceutical Technology and Biopharmaceutics , Ludwig-Maximilians-University Munich , Munich , Germany ix
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