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Exam Prep for: Formulation, Development and Manufacturing of ...

Exam Prep for: Formulation, Development and Manufacturing of ...
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2021
  • Total pages :229
  • ISBN : 1230987654XX
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Summary :

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
  • Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
  • Publisher :Unknown
  • Release Date :2014-10-06
  • Total pages :456
  • ISBN : 9781118870907
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Summary : 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 : Parag Kolhe,Satoshi Ohtake
  • Publisher :Unknown
  • Release Date :2021-06-01
  • Total pages :410
  • ISBN : 9780128143582
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Summary : 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

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
  • Publisher :Unknown
  • Release Date :2004-01-10
  • Total pages :264
  • ISBN : 9780309089791
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Summary : 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.

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
  • Author : Dushyant Varshney,Manmohan Singh
  • Publisher :Unknown
  • Release Date :2015-05-19
  • Total pages :401
  • ISBN : 9781493923830
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Summary : 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.

Development of Vaccines

Development of Vaccines
  • Author : Manmohan Singh,Indresh K. Srivastava
  • Publisher :Unknown
  • Release Date :2011-10-11
  • Total pages :448
  • ISBN : 1118023633
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Summary : 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.

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher :Unknown
  • Release Date :2015-04-01
  • Total pages :710
  • ISBN : 9781493923168
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Summary : This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Sterile Product Development

Sterile Product Development
  • Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
  • Publisher :Unknown
  • Release Date :2013-10-12
  • Total pages :585
  • ISBN : 9781461479789
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Summary : 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.

Department of Homeland Security Appropriations for Fiscal Year 2004

Department of Homeland Security Appropriations for Fiscal Year 2004
  • Author : United States. Congress. Senate. Committee on Appropriations. Subcommittee on the Department of Homeland Security
  • Publisher :Unknown
  • Release Date :2003
  • Total pages :476
  • ISBN : UOM:39015090413660
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Summary :

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
  • Publisher :Unknown
  • Release Date :2014-12-30
  • Total pages :520
  • ISBN : 9780124166615
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Summary : 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

Protecting the Frontline in Biodefense Research

Protecting the Frontline in Biodefense Research
  • Author : National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Committee on Special Immunizations Program for Laboratory Personnel Engaged in Research on Countermeasures for Select Agents
  • Publisher :Unknown
  • Release Date :2011-06-23
  • Total pages :184
  • ISBN : 9780309209274
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Summary : The U.S. Army's Special Immunizations Program is an important component of an overall biosafety program for laboratory workers at risk of exposure to hazardous pathogens. The program provides immunizations to scientists, laboratory technicians and other support staff who work with certain hazardous pathogens and toxins. Although first established to serve military personnel, the program was expanded through a cost-sharing agreement in 2004 to include other government and civilian workers, reflecting the expansion in biodefense research in recent years. Protecting the Frontline in Biodefense Research examines issues related to the expansion of the Special Immunizations Program, considering the regulatory frameworks under which the vaccines are administered, how additional vaccines might be considered for inclusion in the Program, and factors that might influence the development and manufacturing of vaccines for the Special Immunizations Program.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Continuous Manufacturing for the Modernization of Pharmaceutical Production
  • Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
  • Publisher :Unknown
  • Release Date :2019-04-05
  • Total pages :68
  • ISBN : 9780309487818
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Summary : On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Biological Threats and Terrorism

Biological Threats and Terrorism
  • Author : Institute of Medicine,Board on Global Health,Forum on Emerging Infections
  • Publisher :Unknown
  • Release Date :2002-04-07
  • Total pages :335
  • ISBN : 9780309082532
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Summary : In the wake of September 11th and recent anthrax events, our nation’s bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine’s Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.

DNA-Pharmaceuticals

DNA-Pharmaceuticals
  • Author : Martin Schleef
  • Publisher :Unknown
  • Release Date :2006-05-12
  • Total pages :275
  • ISBN : 9783527607006
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Summary : With its focus on a completely novel class of pharmaceuticals, this book collates the hitherto scarce literature about DNA drug formulation keenly desired by biotechnologists, molecular biologists and pharmacists, as well as those working in the biotechnological and pharmaceutical industries. As such, this volume presents a wide range of gene delivery systems needed for different therapeutic applications. It fills the gap between research and clinical trials and describes pharmaceutical fundamentals for the development of efficient DNA pharmaceuticals.

Immunopotentiators in Modern Vaccines

Immunopotentiators in Modern Vaccines
  • Author : Virgil Schijns,Derek O'Hagan
  • Publisher :Unknown
  • Release Date :2005-12-19
  • Total pages :384
  • ISBN : 0080457215
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Summary : Immunopotentiators in Modern Vaccines provides an in-depth insight and overview of a number of most promising immunopotentiators in modern vaccines. In contrast to existing books on the subject it provides recent data on the critical mechanisms governing the activity of vaccine adjuvants and delivery systems. Knowledge of immunological pathways and scenarios of the cells and molecules involved is described and depicted in comprehensive illustrations. Contributions from leading international authorities in the field Well-illustrated, informative figures present the interactions between immunopotentiators and the host immune system Each chapter lists advantages and potential hurdles for achieving a practical application for the specific immunopentiator

The Children's Vaccine Initiative

The Children's Vaccine Initiative
  • Author : Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
  • Publisher :Unknown
  • Release Date :1993-02-01
  • Total pages :240
  • ISBN : 9780309049405
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Summary : The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.

Vaccines

Vaccines
  • Author : Farhat Afrin,Hassan Hemeg,Hani Ozbak
  • Publisher :Unknown
  • Release Date :2017-09-06
  • Total pages :192
  • ISBN : 9789535134756
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Summary : Microbes that elude host's defenses and have developed resistance to the existing antibiotic arsenal continuously invade the human body. Cure for such diseases is inevitable as it may result in high morbidity and mortality, if not properly treated. Vaccination represents the most cost-effective way for disease prevention. Vaccines activate sentinels of the immune system including macrophages and T, B, and dendritic cells to release a battery of effector molecules and cytokines and ward off infection. For long-lasting protection, the memory cells also need to be evoked. This book encompasses biotechnological vaccines in clinical use, cocooning, disease resurgence postvaccination and other vaccine adverse effects, prospects of therapeutic versus prophylactic vaccines, and design of effective vaccines using bioinformatic tools and engineering molecular pattern interactions.

The Role of Diaspora in Technology Transfer and Achieving Sustainable Development in Sudan

The Role of Diaspora in Technology Transfer and Achieving Sustainable Development in Sudan
  • Author : Allam Ahmed
  • Publisher :Unknown
  • Release Date :2009
  • Total pages :214
  • ISBN : UOM:39015080880043
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Summary : This volume includes a wide range (research areas and topics) of papers, projects, proposals and case studies presented during the First Sudanese Diaspora International Conference, held in January 2009 in Brighton, United Kingdom.Sudan like much of the rest of the developing world has toyed with and abided by various approaches or strategies to transfer technology (TT) and achieve sustainable development (SD) without reaping any significant socio-economic benefits. The Sudanese diasporic community is relatively large and has a significant impact on Sudan development on account of the size and volume of financial remittances. However diasporic contribution is largely neglected within national science and technology policies and strategies. Adopting a more holistic approach, the conference aims to provide a stimulus for knowledge exchange and discussion that focuses on issues relating to the role of diaspora in TT and achieving SD to critically examine the relations and links between diaspora, Sudan and host countries, and attempts to outline policy and strategies to support the role of diaspora in developing, creating wealth and achieving SD in Sudan. The conference also aims to learn lessons from the successful communities across the world and emulate the ideas and innovations of these communities by Sudan.It is hoped that the ensemble of papers presented in this volume will help to stimulate debate amongst scholars, researchers and policymakers and that readers will find this volume interesting and thought-provoking. The seven main sections include: Diaspora Contribution to Home CountryTechnology and Scientific Knowledge TransferEducation, Training and DevelopmentMedical Sciences and Public HealthEngineering Applications and Sustainable Business ExcellenceEnvironment and Waste ManagementAbstracts for Oral Presentations

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 9780470595879
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Summary : 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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications
  • Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
  • Publisher :Unknown
  • Release Date :2020-04-13
  • Total pages :400
  • ISBN : 9783527341122
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Summary : A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

Carbohydrate-Based Vaccines

Carbohydrate-Based Vaccines
  • Author : A. Krishna Prasad
  • Publisher :Unknown
  • Release Date :2019-09-23
  • Total pages :416
  • ISBN : 0841233373
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Summary : The past three decades have witnessed the development and regulatory approval of glycoconjugate vaccines against several medically important bacterial pathogens, including Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitides, and Salmonella typhi. Immunologic protection against these and many other bacterial diseases is mediated through opsonophagocytic antibodies directed against the surface carbohydrates that define the bacterial serogroup or serotype and serve as virulence factors. These vaccines are composed of bacterial capsular polysaccharides chemically conjugated to immunogenic carrier proteins. Given that the diseases caused by these bacterial pathogens are most pronounced in infants and young children, the development of the glycoconjugate vaccine technology has had a considerable impact on public health. Many of the chapters in this volume were assembled as a follow-up from a symposium entitled "Carbohydrate-Based Vaccines and Adjuvants" which took place at the 254th American Chemical Society National Meeting held in Washington, DC (August 2017). The symposium was sponsored by Pfizer and the Carbohydrate (CARB) and Biotechnology (BIOT) divisions. This book, therefore, reflects the importance of this field toward design, development, manufacture and licensure of the complex carbohydrate-based (glycoconjugate) vaccines. The book has been organized into thirteen chapters, which cover a comprehensive landscape including the clinical history, design, development, chemistry, manufacturing and control (CMC) aspects, pre-clinical assays, adjuvants and the various approaches used to develop carbohydrate-based vaccines.