Guidelines for the international packaging and shipping of vaccines

Guidelines for the international packaging and shipping of vaccines PDF

Author:

Publisher: World Health Organization

Published: 2020-12-22

Total Pages: 169

ISBN-13: 9240015434

DOWNLOAD EBOOK →

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.

Practical Aspects of Vaccine Development

Practical Aspects of Vaccine Development PDF

Author: Parag Kolhe

Publisher: Academic Press

Published: 2021-09-10

Total Pages: 388

ISBN-13: 0128143584

DOWNLOAD EBOOK →

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

Travelers' Vaccines

Travelers' Vaccines PDF

Author: Jane N. Zuckerman

Publisher: PMPH-USA

Published: 2010

Total Pages: 586

ISBN-13: 1607950456

DOWNLOAD EBOOK →

Rev. ed. of: Travelers' vaccines / Elaine C. Jong, Jane N. Zuckerman. 2004.

Delivery Systems for Tuberculosis Prevention and Treatment

Delivery Systems for Tuberculosis Prevention and Treatment PDF

Author: Anthony J. Hickey

Publisher: John Wiley & Sons

Published: 2016-08-25

Total Pages: 456

ISBN-13: 1118943201

DOWNLOAD EBOOK →

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

WHO Expert Committee on Biological Standardization

WHO Expert Committee on Biological Standardization PDF

Author: WHO Expert Committee on Biological Standardization. Meeting

Publisher: World Health Organization

Published: 2013

Total Pages: 398

ISBN-13: 924120978X

DOWNLOAD EBOOK →

"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development PDF

Author: Feroz Jameel

Publisher: Springer

Published: 2015-04-01

Total Pages: 710

ISBN-13: 1493923161

DOWNLOAD EBOOK →

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.

Guidelines for Smallpox Vaccine Packing & Shipping

Guidelines for Smallpox Vaccine Packing & Shipping PDF

Author:

Publisher:

Published: 2007

Total Pages:

ISBN-13:

DOWNLOAD EBOOK →

The National Immunization Program of the Centers for Disease Control and Prevention has prepared the following guidelines for smallpox vaccine packing and shipping. These guidelines are based in part on CDC's research on different shipping and handling methods under strenuous test conditions. These guidelines are not intended to be rules and regulations. They are suggestions written primarily for personnel who pack and ship vaccines.

Lanterna Rally - Theme by Grace Themes