Practical Aspects of Vaccine Development

• Author : Parag Kolhe,Satoshi Ohtake
• Publisher : Elsevier
• Release : 24 September 2021

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

• Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
• Publisher : John Wiley & Sons
• Release : 06 October 2014

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

• Author : Institute of Medicine,Board on Health Care Services,Committee on the Evaluation of Vaccine Purchase Financing in the United States
• Publisher : National Academies Press
• Release : 10 January 2004

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

• Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
• Publisher : National Academies Press
• Release : 05 April 2019

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

• 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 : National Academies Press
• Release : 23 June 2011

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

• Author : Manmohan Singh,Indresh K. Srivastava
• Publisher : John Wiley & Sons
• Release : 11 October 2011

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

• Author : Dushyant Varshney,Manmohan Singh
• Publisher : Springer
• Release : 19 May 2015

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

• Author : Institute of Medicine,Board on Global Health,Forum on Emerging Infections
• Publisher : National Academies Press
• Release : 07 April 2002

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,

• Author : Stanley A. Plotkin,Walter A. Orenstein,Paul A. Offit
• Publisher : Unknown Publisher
• Release : 01 September 2017

• Author : Emily P. Wen,Ronald Ellis,Narahari S. Pujar
• Publisher : John Wiley & Sons
• Release : 17 November 2014

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

• Author : Wei Wang,Manmohan Singh
• Publisher : John Wiley & Sons
• Release : 29 August 2013

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,

• Author : Parag Kolhe,Satoshi Ohtake
• Publisher : Academic Press
• Release : 17 September 2021

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

• Author : Institute of Medicine,Committee on the Children's Vaccine Initiative: Planning Alternative Strategies
• Publisher : National Academies Press
• Release : 01 February 1993

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

• Author : Feroz Jameel,Susan Hershenson
• Publisher : John Wiley & Sons
• Release : 13 July 2010

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

• Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
• Publisher : John Wiley & Sons
• Release : 03 February 2020

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