Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development
Author: Parag Kolhe,Satoshi Ohtake
Publsiher: Elsevier
Total Pages: 386
Release: 2021-09-24
ISBN 10: 0128143576
ISBN 13: 9780128143575
Language: EN, FR, DE, ES & NL

Practical Aspects of Vaccine Development Book Review:

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. 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 its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for 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 Considers process development for solution, suspension and lyophilized products Explores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

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

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.

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
Publsiher: National Academies Press
Total Pages: 184
Release: 2011-06-23
ISBN 10: 0309209277
ISBN 13: 9780309209274
Language: EN, FR, DE, ES & NL

Protecting the Frontline in Biodefense Research Book Review:

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.

The Children s Vaccine Initiative

The Children s Vaccine Initiative
Author: Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
Publsiher: National Academies Press
Total Pages: 240
Release: 1993-02-01
ISBN 10: 0309049407
ISBN 13: 9780309049405
Language: EN, FR, DE, ES & NL

The Children s Vaccine Initiative Book Review:

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.

Vaccine Development and Manufacturing

Vaccine Development and Manufacturing
Author: Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publsiher: John Wiley & Sons
Total Pages: 464
Release: 2014-11-17
ISBN 10: 0470261943
ISBN 13: 9780470261941
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: Parag Kolhe,Satoshi Ohtake
Publsiher: Academic Press
Total Pages: 386
Release: 2021-09-17
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

Vaccine Supply and Innovation

Vaccine Supply and Innovation
Author: National Research Council,Institute of Medicine,Division of Health Promotion and Disease Prevention
Publsiher: National Academies Press
Total Pages: 210
Release: 1985-02-01
ISBN 10: 0309035449
ISBN 13: 9780309035446
Language: EN, FR, DE, ES & NL

Vaccine Supply and Innovation Book Review:

The United States is facing a vaccine shortage that may threaten public health. This book examines vaccine research and development, production and supply, and utilization and offers recommendations aimed at ensuring vaccine supply and promoting innovation. In addition, this comprehensive volume provides information on the adverse reactions associated with the range of vaccines used in the United States and contains the most thorough analysis ever published on the state of the law regarding vaccine-related injury and compensation for vaccine injury.

Carbohydrate Based Vaccines

Carbohydrate Based Vaccines
Author: A. Krishna Prasad
Publsiher: Unknown
Total Pages: 416
Release: 2019-09-23
ISBN 10: 9780841233379
ISBN 13: 0841233373
Language: EN, FR, DE, ES & NL

Carbohydrate Based Vaccines Book Review:

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.

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
Publsiher: Springer
Total Pages: 710
Release: 2015-04-01
ISBN 10: 1493923161
ISBN 13: 9781493923168
Language: EN, FR, DE, ES & NL

Quality by Design for Biopharmaceutical Drug Product Development Book Review:

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.

The Vaccine Book

The Vaccine Book
Author: Barry R. Bloom,Paul-Henri Lambert
Publsiher: Academic Press
Total Pages: 664
Release: 2016-06-23
ISBN 10: 012805400X
ISBN 13: 9780128054000
Language: EN, FR, DE, ES & NL

The Vaccine Book Book Review:

The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child’s risk. Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines Gives new ideas about future vaccines and concepts Introduces new vaccines and concepts Gives ideas about challenges facing public and private industrial investors in the vaccine area Discusses the problem of declining immunization rates and vaccine hesitancy

Hope for the Future Developing an Hiv aids Vaccine

Hope for the Future   Developing an Hiv aids Vaccine
Author: Anonim
Publsiher: DIANE Publishing
Total Pages: 135
Release: 2022
ISBN 10: 1422333000
ISBN 13: 9781422333006
Language: EN, FR, DE, ES & NL

Hope for the Future Developing an Hiv aids Vaccine Book Review:

Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book

Epidemiology and Prevention of Vaccine Preventable Diseases  13th Edition E Book
Author: Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe
Publsiher: Public Health Foundation
Total Pages: 512
Release: 2015-10-19
ISBN 10: 0990449122
ISBN 13: 9780990449126
Language: EN, FR, DE, ES & NL

Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book Book Review:

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact [email protected] for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

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.

Delivery Systems for Tuberculosis Prevention and Treatment

Delivery Systems for Tuberculosis Prevention and Treatment
Author: Anthony J. Hickey
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2016-08-25
ISBN 10: 1118943201
ISBN 13: 9781118943205
Language: EN, FR, DE, ES & NL

Delivery Systems for Tuberculosis Prevention and Treatment Book Review:

Provides a review of novel pharmaceutical approaches for Tuberculosis drugs Presents a novel perspective on tuberculosis prevention and treatment Considers the nature of disease, immunological responses, vaccine and drug delivery, disposition and response Multidisciplinary appeal, with contributions from microbiology, immunology, molecular biology, pharmaceutics, pharmacokinetics, chemical and mechanical engineering

Antiviral Discovery for Highly Pathogenic Emerging Viruses

Antiviral Discovery for Highly Pathogenic Emerging Viruses
Author: Rafael Delgado,Cesar Munoz-Fontela
Publsiher: Royal Society of Chemistry
Total Pages: 290
Release: 2021-12-08
ISBN 10: 1788015649
ISBN 13: 9781788015646
Language: EN, FR, DE, ES & NL

Antiviral Discovery for Highly Pathogenic Emerging Viruses Book Review:

Ideal for drug discovery scientists and medicinal chemists with an interest in antiviral drug discovery and development, this book provides a complete overview of the latest progress in the field, recent advances and the challenges that remain in developing these highly pathogenic agents.

Biological Threats and Terrorism

Biological Threats and Terrorism
Author: Institute of Medicine,Board on Global Health,Forum on Emerging Infections
Publsiher: National Academies Press
Total Pages: 335
Release: 2002-04-07
ISBN 10: 0309082536
ISBN 13: 9780309082532
Language: EN, FR, DE, ES & NL

Biological Threats and Terrorism Book Review:

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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications
Author: Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2020-02-03
ISBN 10: 3527802096
ISBN 13: 9783527802098
Language: EN, FR, DE, ES & NL

Drying Technologies for Biotechnology and Pharmaceutical Applications Book Review:

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.

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.

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics
Author: Lisa Plitnick,Danuta Herzyk
Publsiher: Academic Press
Total Pages: 432
Release: 2013-06-27
ISBN 10: 0123948231
ISBN 13: 9780123948236
Language: EN, FR, DE, ES & NL

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics Book Review:

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields