Exam Prep for Formulation Development and Manufacturing of

Exam Prep for  Formulation  Development and Manufacturing of
Author: Anonim
Publsiher: Anonim
Total Pages: 329
Release:
ISBN 10:
ISBN 13:
Language: EN, FR, DE, ES & NL

Exam Prep for Formulation Development and Manufacturing of Book Review:

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
Author: Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2014-10-06
ISBN 10: 1118870905
ISBN 13: 9781118870907
Language: EN, FR, DE, ES & NL

Vaccine Development and Manufacturing Book Review:

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development
Author: Satoshi Ohtake,Parag Kolhe
Publsiher: Academic Press
Total Pages: 410
Release: 2020-12-01
ISBN 10: 0128143584
ISBN 13: 9780128143582
Language: EN, FR, DE, ES & NL

Practical Aspects of Vaccine Development Book Review:

Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines Covers process development for solution, suspension, and lyophilized products Explores the future of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
Author: Dushyant Varshney,Manmohan Singh
Publsiher: Springer
Total Pages: 401
Release: 2015-05-19
ISBN 10: 1493923838
ISBN 13: 9781493923830
Language: EN, FR, DE, ES & NL

Lyophilized Biologics and Vaccines Book Review:

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Biological Drug Products

Biological Drug Products
Author: Wei Wang,Manmohan Singh
Publsiher: John Wiley & Sons
Total Pages: 744
Release: 2013-08-29
ISBN 10: 1118695224
ISBN 13: 9781118695227
Language: EN, FR, DE, ES & NL

Biological Drug Products Book Review:

Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
Author: Sandeep Nema,John D. Ludwig
Publsiher: CRC Press
Total Pages: 1125
Release: 2019-08-08
ISBN 10: 042957472X
ISBN 13: 9780429574726
Language: EN, FR, DE, ES & NL

Parenteral Medications Fourth Edition Book Review:

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Vaccinology

Vaccinology
Author: Gregg N. Milligan,Alan D. T. Barrett
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2014-12-04
ISBN 10: 111863652X
ISBN 13: 9781118636527
Language: EN, FR, DE, ES & NL

Vaccinology Book Review:

Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing
Author: Ganapathy Subramanian
Publsiher: John Wiley & Sons
Total Pages: 528
Release: 2014-12-03
ISBN 10: 3527673709
ISBN 13: 9783527673704
Language: EN, FR, DE, ES & NL

Continuous Processing in Pharmaceutical Manufacturing Book Review:

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Vaccines

Vaccines
Author: Stanley A. Plotkin,Walter A. Orenstein,Paul A. Offit
Publsiher: Elsevier Health Sciences
Total Pages: 1725
Release: 2008
ISBN 10: 1416036113
ISBN 13: 9781416036111
Language: EN, FR, DE, ES & NL

Vaccines Book Review:

Completely revised and updated, this respected reference offers comprehensive and current coverage of every aspect of vaccination--from development to use in reducing disease. It also includes access to a companion Web site for more coverage.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Author: William J. Brock,Barbara Mounho,Lijie Fu
Publsiher: John Wiley & Sons
Total Pages: 560
Release: 2014-05-02
ISBN 10: 1118874080
ISBN 13: 9781118874080
Language: EN, FR, DE, ES & NL

The Role of the Study Director in Nonclinical Studies Book Review:

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Financing Vaccines in the 21st Century

Financing Vaccines in the 21st Century
Author: Institute of Medicine,Board on Health Care Services,Committee on the Evaluation of Vaccine Purchase Financing in the United States
Publsiher: National Academies Press
Total Pages: 264
Release: 2004-01-10
ISBN 10: 0309089794
ISBN 13: 9780309089791
Language: EN, FR, DE, ES & NL

Financing Vaccines in the 21st Century Book Review:

The national immunization system has achieved high levels of immunization, particularly for children. However, this system faces difficult challenges for the future. Significant disparities remain in assuring access to recommended vaccines across geographic and demographic populations. These disparities result, in part, from fragmented publicâ€"private financing in which a large number of children and adults face limited access to immunization services. Access for adults lags well behind that of children, and rates of immunizations for those who are especially vulnerable because of chronic health conditions such as diabetes or heart and lung disease, remain low. Financing Vaccines in the 21st Century: Assuring Access and Availability addresses these challenges by proposing new strategies for assuring access to vaccines and sustaining the supply of current and future vaccines. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a research agenda to facilitate implementation of the plan.

Development of Novel Vaccines

Development of Novel Vaccines
Author: Alexander von Gabain,Christoph Klade
Publsiher: Springer Science & Business Media
Total Pages: 306
Release: 2012-04-23
ISBN 10: 3709107091
ISBN 13: 9783709107096
Language: EN, FR, DE, ES & NL

Development of Novel Vaccines Book Review:

“Development of novel vaccines” gives an overview of the tasks in basic research leading to the final product – the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.

Development of Vaccines

Development of Vaccines
Author: Manmohan Singh,Indresh K. Srivastava
Publsiher: John Wiley & Sons
Total Pages: 448
Release: 2011-10-11
ISBN 10: 9781118023631
ISBN 13: 1118023633
Language: EN, FR, DE, ES & NL

Development of Vaccines Book Review:

Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.

Influenza Vaccine Federal Investments in Alternative Technologies and Challenges to Development and Licensure

Influenza Vaccine  Federal Investments in Alternative Technologies and Challenges to Development and Licensure
Author: Marcia Crosse
Publsiher: DIANE Publishing
Total Pages: 58
Release: 2011-10-07
ISBN 10: 1437988296
ISBN 13: 9781437988291
Language: EN, FR, DE, ES & NL

Influenza Vaccine Federal Investments in Alternative Technologies and Challenges to Development and Licensure Book Review:

Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Dept. of Health and Human Services (HHS) and the Dept. of Defense (DOD) support the development of technologies that can be used in producing technologies that can be used in producing influenza vaccines. HHS's Food and Drug Admin. (FDA) reviews licensing applications for new vaccine, and the Dept. of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. This report examines (1) federal funding from FY 2005 through March 2011 for alternative technologies and the status of manufacturers' efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. Tables and figures. This is a print on demand report.

Novel Approaches and Strategies for Biologics Vaccines and Cancer Therapies

Novel Approaches and Strategies for Biologics  Vaccines and Cancer Therapies
Author: Manmohan Singh,Maya Salnikova
Publsiher: Academic Press
Total Pages: 520
Release: 2014-12-30
ISBN 10: 012416661X
ISBN 13: 9780124166615
Language: EN, FR, DE, ES & NL

Novel Approaches and Strategies for Biologics Vaccines and Cancer Therapies Book Review:

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies. Provides strategies for the development of safe and efficacious novel formulations for various modalities of biologics, vaccines and for cancer therapy Highlights novel cases from current clinical trials as well as marketed products Reviews overall successes and challenges in the development of novel formulations, including new molecular targets for the treatment of diseases, design of target-specific therapies, regulatory considerations, individualized therapies

Novel Technologies for Vaccine Development

Novel Technologies for Vaccine Development
Author: Igor S Lukashevich,Haval Shirwan
Publsiher: Springer
Total Pages: 386
Release: 2014-11-13
ISBN 10: 3709118182
ISBN 13: 9783709118184
Language: EN, FR, DE, ES & NL

Novel Technologies for Vaccine Development Book Review:

This book presents a detailed overview of the development of new viral vector-based vaccines before discussing two major applications: preventive vaccines for infectious diseases and therapeutic cancer vaccines. Viral vector-based vaccines hold a great potential for development into successful pharmaceutical products and several examples at the advanced pre-clinical or clinical stage are presented. Nevertheless, the most efforts were focused on novel and very innovative technologies for new generation of vector-based vaccines. Furthermore, specific topics such as delivery and adjuvant and protection strategies for cell-mediated-based vaccines are presented. Given its scope, the book is a “must read” for all those involved in vaccine development, both in academia and industrial vaccine development.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Author: Feroz Jameel,Susan Hershenson
Publsiher: John Wiley & Sons
Total Pages: 984
Release: 2010-08-09
ISBN 10: 0470118121
ISBN 13: 9780470118122
Language: EN, FR, DE, ES & NL

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book Review:

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Sterile Product Development

Sterile Product Development
Author: Parag Kolhe,Mrinal Shah,Nitin Rathore
Publsiher: Springer Science & Business Media
Total Pages: 585
Release: 2013-10-12
ISBN 10: 1461479789
ISBN 13: 9781461479789
Language: EN, FR, DE, ES & NL

Sterile Product Development Book Review:

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Vaccine Analysis Strategies Principles and Control

Vaccine Analysis  Strategies  Principles  and Control
Author: Brian K. Nunnally,Vincent E. Turula,Robert D. Sitrin
Publsiher: Springer
Total Pages: 665
Release: 2014-11-27
ISBN 10: 3662450240
ISBN 13: 9783662450246
Language: EN, FR, DE, ES & NL

Vaccine Analysis Strategies Principles and Control Book Review:

This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure.

Mucosal Vaccines

Mucosal Vaccines
Author: Pamela A. Kozlowski
Publsiher: Springer Science & Business Media
Total Pages: 198
Release: 2012-01-13
ISBN 10: 3642236928
ISBN 13: 9783642236921
Language: EN, FR, DE, ES & NL

Mucosal Vaccines Book Review:

This volume is focused on the development of vaccines which generate immune effectors capable of blocking mucosal entry or peripheral pathogen spread. A critical first step in the design of mucosal vaccines is the selection of administration route. Not all mucosal immunization routes are created equally when it comes to eliciting immune responses in multiple body compartments. This subject and situations when a mucosal route may not be required for vaccine delivery are reviewed here with an emphasis on the sublingual immunization route, which may offer a safer alternative to the nasal route for induction of broadly disseminated immune responses. External host defenses that inhibit entry of microorganisms at mucosal surfaces also pose obstacles to the efficient internalization of mucosally-applied vaccines. Transcutaneous immunization with appropriate adjuvants and permeation enhancers can induce mucosal immune responses and may be advantageous for bypassing these luminal barriers. Other chapters describe strategies for enhancing uptake of mucosal vaccines, for instance through targeted delivery to antigen-sampling M cells, construction of virus-like particles which mimic natural pathogens, addition of mucoadhesives or formulation as nanoparticles. Topics include edible vaccines as well as plant-based production of subunit or particulate vaccines that could be administered by any route. Dry powder vaccines that could be insufflated or directly applied to mucosal surfaces may be particularly ideal for mass vaccination in developing countries. The manufacture, stability and efficacy of powder formulations is comprehensively reviewed. We conclude with chapters on two of the greatest challenges facing mucosal vaccine development: human immunodeficiency virus and bioterrorist agents. This monograph highlights progress and information that should prove invaluable for the development of contemporary vaccines that prevent infection by these and other mucosal pathogens.