Guidelines On The International Packaging And Shipping Of Vaccines
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Author | : |
Publisher | : World Health Organization |
Total Pages | : 169 |
Release | : 2020-12-22 |
Genre | : Medical |
ISBN | : 9240015434 |
International shipping of vaccines is the first leg of the complex journey that vaccines undertake to reach the end users in a country. Particular challenges include the size and weight of packages, implementation of quality control checks at reception, ensuring environmental sustainability, and maintaining required temperatures during the journey. Although there are many possibilities of transport e.g. sea freight and terrestrial transportation, air freight currently remains the most widely used means of transport for vaccines. In recognition of this fact, these guidelines apply predominantly to the air freighting of vaccines. Transportation of vaccines from the manufacturing facility to the airport facility require the use of ground transportation, and reference is also made to the qualification of refrigerated road vehicles as well. The objective of these guidelines is to provide technical guidance to help ensure the quality of vaccines during all stages of the international air transportation process. These guidelines are applicable to all persons and institutions involved in international air shipment of vaccines from the premises of the product manufacturer to the recipient country. This includes all parties involved in shipment, vaccine manufacturers, logistics service providers (LSPs), freight forwarders, carriers and their employees. The relevant sections of these guidelines should also be considered for implementation by UN procurement agencies and other international procurement organizations, countries, donor agencies and certifying bodies.
Author | : Parag Kolhe |
Publisher | : Academic Press |
Total Pages | : 388 |
Release | : 2021-09-10 |
Genre | : Medical |
ISBN | : 0128143584 |
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
Author | : |
Publisher | : UNICEF |
Total Pages | : 15 |
Release | : 2004 |
Genre | : Vaccination of children |
ISBN | : |
Author | : Jane N. Zuckerman |
Publisher | : PMPH-USA |
Total Pages | : 586 |
Release | : 2010 |
Genre | : Medical |
ISBN | : 1607950456 |
Rev. ed. of: Travelers' vaccines / Elaine C. Jong, Jane N. Zuckerman. 2004.
Author | : Feroz Jameel |
Publisher | : Springer |
Total Pages | : 710 |
Release | : 2015-04-01 |
Genre | : Medical |
ISBN | : 1493923161 |
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.
Author | : Anthony J. Hickey |
Publisher | : John Wiley & Sons |
Total Pages | : 456 |
Release | : 2016-08-25 |
Genre | : Science |
ISBN | : 1118943201 |
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
Author | : WHO Expert Committee on Biological Standardization. Meeting |
Publisher | : World Health Organization |
Total Pages | : 398 |
Release | : 2013 |
Genre | : Medical |
ISBN | : 924120978X |
"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.
Author | : Vijay Kumar Prajapati |
Publisher | : Academic Press |
Total Pages | : 438 |
Release | : 2022-08-20 |
Genre | : Medical |
ISBN | : 032389786X |
Emergence of new and deadly infectious diseases is significantly deteriorating the human health. Development of vaccine by the scientist has become an important weapon to control the spread of infectious diseases as well as to improve the life expectancy at global level in 20th-21st Century. This book will provide the in-depth knowledge of vaccine history, and development of new strategies to design efficacious and safe vaccine molecule. This book will cover the development of system vaccinology and their applications revolutionize the vaccine discovery. This will provide a resource for the basic and clinical researcher working to human life expectancy by their vaccine experiments and clinical trials. My purpose to write this book to educate the students and researchers with modern development in the field of vaccinology and empowering the researcher with new tools and methodology for developing potential and immunogenic vaccines. This book will be helpful to solve the curiosity of science and medical background students related with vaccinology and will be helpful to devise a new vaccine molecule to control the spread of new and emerging pathogens. Systems biology is a rapidly expanding research discipline aiming to integrate multifaceted datasets generated using state-of-the-art high- throughput technologies such as arrays and next-generation sequencing. Combined with sophisticated computational analysis we are able to interrogate host responses to infections and vaccination on a systems level, thus generating important new hypotheses and discovering unknown associations between immunological parameters. - Provides in-depth knowledge of vaccine history - Covers the development of system vaccinology and their applications revolutionize the vaccine discovery - Gives insights to the development of new strategies to design efficacious and safe vaccine molecule - Provides a resource for the basic and clinical researcher working to human life expectancy by their vaccine experiments and clinical trials - Highlights the importance of differential miRNA expression, microbiome after vaccination for human health - Serves the need of students and researcher for applying computational tools and quick designing of potential molecule which may be proposed for vaccine trial - Take the decisions to perform the kind of experiments for assessment of vaccine immunogenicity - Aims to understand disease pathogenesis and host responses to infection and vaccination - Offers a seamless continuum of scientific discovery and vaccine invention
Author | : Stefan G. Stanciu |
Publisher | : BoD – Books on Demand |
Total Pages | : 156 |
Release | : 2016-08-24 |
Genre | : Science |
ISBN | : 9535125303 |
Countless healthcare and biomedical solutions with high impact in terms of timely diagnostics, therapeutic success, patient comfort or financial sustainability of healthcare systems rely on micro- and nanotechnologies. Thus, it is not at all exaggerate to claim that such technologies play in current days a tremendous role with respect to improving the quality of our life, health and well-being, which are the main priorities of modern science. This volume illustrates these statements, addressing highly significant scientific subjects from diverse areas of micro- and nanotechnologies for biotechnology. Authoritative voices in their fields present in this volume their work, or review recent trends, concepts and applications, in a manner that is accessible to a broad readership audience from both within and outside their specialist area.
Author | : George Mc Guire |
Publisher | : George Mc Guire |
Total Pages | : 1441 |
Release | : 2015-10-31 |
Genre | : |
ISBN | : |