This comprehensive volume compiles the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. Twenty-one chapters are divided into four main parts: (I) Background; (2) Delivery Systems for Subunit Vaccines; (3) Delivery Routes, Devices and Dosage Forms; and (4) Pharmaceutical Analysis and Quality Control of Vaccines. Part one provide a basic background with respect to immunology and general vaccine classification. In part two, it presents representative types of vaccine delivery systems individually with focus on the physicochemical properties of the systems and their significance for the immune response they stimulate. These delivery systems include aluminum adjuvants, emulsions, liposomes, bilosomes, cubosomes/hexosomes, ISCOMs, virus-like particles, polymeric nano- and microparticles, gels, implants and cell-based delivery systems.

Following these chapters, part three addresses the challenges associated with vaccine delivery via specific routes of administrationin particular subcutaneous, intramuscular, oral, nasal, pulmonary, transdermal and vaginal administration. Furthermore, the specific administration routes are discussed in combination with device technologies relevant for the respective routes as well as dosage forms appropriate for the device technology. Finally, the fourth part concerns pharmaceutical analysis and quality control of subunit vaccines.

Provides a comprehensive overview of the scientific and global regulatory challenges facing scientists who research and develop subunit vaccines Discusses vaccine delivery systems individually with focus on the physicochemical properties of the systems and their significance for the immune response they stimulate Addresses the challenges associated with vaccine delivery via specific routes of administration Includes supplementary material: sn.pub/extras

Autorentext

Associate Professor Camilla Foged is Head of the Vaccine Design and Delivery Group in Section of Biologics, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark. She has an MSc in Biochemistry from University of Copenhagen. Dr. Foged attained her PhD from The Danish University of Pharmaceutical Sciences. Her main research interest is advanced drug delivery aiming at designing new vaccine and nucleic acid delivery systems to improve therapy. Her group efficiently has addressed drug delivery challenges with cutting edge technologies, which has enabled high impact publications and innovative solutions in drug delivery. The group's research goal is to improve disease prevention and treatment by designing nanoparticulate vaccine and nucleic acid formulations through in-depth knowledge of how the physicochemical properties of the particles affect their interaction with the environment, e.g. in formulation, in vitro and in vivo. Dr. Foged is interested in lipid- and polymer-based nanoparticulate delivery systems using various approaches for targeting and membrane destabilization.

Professor Thomas Rades is the Research Chair in Pharmaceutical Design and Drug Delivery in the Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark. Dr. Rades obtained his PhD from the University of Braunschweig, Germany, and he has developed an international reputation for his research on solid dosage forms as well as in vaccine delivery using nanoparticulate systems. Research in both areas aims to improve drug therapy through appropriate formulation and physicochemical characterisation of medicines and vaccines. It combines physical, chemical, and biological sciences and technology to optimally formulate drugs and vaccines for human and veterinary uses. Professor Rades has published more than 270 papers in international peer review journals.

Professor Yvonne Perrie is Head of Pharmacy and Chair in Drug Delivery withinAston Pharmacy School, Aston University, Birmingham, UK. Dr. Perrie attained her PhD from the University of London under the supervision of Professor Gregoriadis. Her research is multi-disciplinary and is focused on the development of drug carrier systems to facilitate the delivery of drugs and vaccines, providing practical solutions for current healthcare problems. Dr. Perrie is a Fellow of the Society of Biology and an Eminent Fellow of the Academy of Pharmaceutical Sciences. Externally, she is a Director-at-large for the Controlled Release Society and Editor of the Controlled Release Society Newsletter. She is Editor-in-Chief of the Journal of Liposome Research and Pharmaceutics, and she is associate editor for the Journal of Drug Targeting and the Journal of Pharmacy and Pharmacology.

Professor Sarah Hook is the Professor of Biopharmaceutics of the School of Pharmacy at the University of Otago, Dunedin, New Zealand, where she obtained her PhD in immunology. Her area of interest is in the development and testing (physical, chemical and immunological) of novel formulations for the delivery of small and large molecule drugs for the prevention and treatment of both communicable and non-communicable diseases.

Inhalt

1 Immunological Background.- 2 Classification of Vaccines.- 3 Aluminum Adjuvants - Basic Concepts and Progress in Understanding.- 4 Emulsions as Vaccine Adjuvants.- 5 The application of liposomes as vaccine adjuvants.- 6 Developing Bilayer-based Delivery Systems for Oral Delivery of Subunit Vaccines.- 7 Cubosomes Structure, Preparation and Use as an Antigen Delivery System.- 8 ISCOMs as a Vaccine Delivery System.- 9 Virus-like Particles, a Versatile Subunit Vaccine Platform.- 10 Polymeric Particulates for Subunit Vaccine Delivery.- 11 Gels as Vaccine Delivery Systems.- 12 Implants as Sustained Release Delivery Devices for Vaccine Antigens.- 13 Dendritic Cell-based Vaccines.- 14 Parenteral Vaccine Administration Tried and True.- 15 Nasal Administration of Vaccines.- 16 Pulmonary Administration of Subunit Vaccines.- 17 Vaginal Delivery of Subunit Vaccines.- 18 Transcutaneous Administration.- 19 Pharmaceutical Analysis and Quality Control of Vaccines.- 20 The Physical Analysis of Vaccines.- 21 Characterizing the Association between Antigens and Adjuvants.