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Author: World Health Organization
Publisher: World Health Organization
Published: 2024-06-25
Total Pages: 72
ISBN-13: 9240096019
DOWNLOAD EBOOKAuthor: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2019-04-05
Total Pages: 69
ISBN-13: 0309487811
DOWNLOAD EBOOKOn 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.
Author: Vesper
Publisher: David Horwood International Pub Limited
Published: 2000-07
Total Pages: 224
ISBN-13: 9781930114173
DOWNLOAD EBOOKAuthor: Ciro A. de Quadros
Publisher: Pan American Health Org
Published: 2004
Total Pages: 410
ISBN-13: 9275115966
DOWNLOAD EBOOKThis publication contains a number of papers which consider the public health role of vaccines in improving the health of the world's populations, and looks at the challenges of using immunisation to combat emerging and re-emerging diseases. Issues discussed include the innovative use of vaccines against diseases such as meningococcal infection in Africa, Haemophilus influenza type b, varicella, and hepatitis, efforts to develop a new generation of vaccines against cholera and typhoid, shigella and Helicobacter pylori, as well as developments in the quest for vaccines against tuberculosis, HIV/AIDS, dengue, malaria, and hookworm. It also deals with the use of vaccines to fight bioterrorism attacks; regulatory and safety issues; financing issues, impact of health sector reform and the sustainability of immunisation programmes.
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Publisher:
Published: 1987
Total Pages: 32
ISBN-13:
DOWNLOAD EBOOKAuthor: World Health Organization
Publisher: World Health Organization
Published: 2024-05-06
Total Pages: 84
ISBN-13: 9240092765
DOWNLOAD EBOOKThe Local Production and Assistance (LPA) Unit in the Regulation and Prequalification Department (RPQ), Access to Medicines and Health Products Division (MHP), WHO, supports Member States (MS), particularly low- and middle-income countries (LMICs), to strengthen sustainable local production and technology transfer to improve timely, equitable access to quality, safe and effective essential medical products. The LPA Unit provides assistance and support to MS with an ecosystem-wide and holistic approach, such as fostering global coordination and partnerships, conducting ecosystem assessments for sustainable, quality local production, developing and implementing strategies/roadmaps, providing comprehensive capacity building and technical assistance, including for WHO Prequalification (PQ)/Emergency Use Listing (EUL), facilitating technology transfer (TT) and developing global resources on local production and TT. A landmark resolution WHA74.6 on strengthening local production of medicines and other health technologies to improve access was adopted in the Seventy-fourth World Health Assembly, signalling globally the important role local production plays in improving access and strengthening health security. Within this mandate, the LPA Unit, developed a series of case studies on the ecosystem for local production of pharmaceuticals, vaccines and biologicals, with a focus on country context in the low-and middle-income countries. These case studies add to the existing repository of resources on strengthening local production and technology transfer of health products for countries to leverage upon when countries embark in these areas. The countries in this series are Bangladesh, Kenya, Nigeria, Pakistan, Senegal and Tunisia. From July to September 2022, a series of interviews and consultative meetings, including a review of available literature, policies and other documents, and administration of a questionnaire, were performed. This case study is intended to report the collated information in areas such as available policies, initiatives, financing, regulatory system, patent protection system, research and development work, markets and capacity and preparedness to uptake local production of quality-assured pharmaceuticals, vaccines (including mRNA vaccines), and biologicals. The expectations and needs of these countries were also collected and included in the case study, along with proposed recommendations, for the reader to see various viewpoints towards strengthening sustainable local production and achieving universal health coverage and the Sustainable Development Goals.
Author: Barry R. Bloom
Publisher: Academic Press
Published: 2016-06-23
Total Pages: 666
ISBN-13: 012805400X
DOWNLOAD EBOOKThe 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
Author: Pratyoosh Shukla
Publisher: Springer
Published: 2015-11-16
Total Pages: 223
ISBN-13: 8132226100
DOWNLOAD EBOOKThis excellent book covers wide-ranging topics in interdisciplinary microbiology, addressing various research aspects and highlighting advanced discoveries and innovations. It presents the fascinating topic of modern biotechnology, including agricultural microbiology, microalgae biotechnology, bio-energy, bioinformatics and metagenomics, environmental microbiology, enzyme technology and marine biology. It presents the most up-to-date areas of microbiology with an emphasis on shedding light on biotechnological advancements and integrating these interdisciplinary microbiology research topics into other biotechnology sub-disciplines. The book raises awareness of the industrial relevance of microbiology, which is key component of this unique collection. The topics include production of antioxidant-glutathione, enzyme-engineering methods, probiotic microbiology and features of microbial xylanases. It also covers some other remarkable aspects of microbiology, like potential health hazards in recreational water and fullerene nanocomposites, which are vital for biotechnological interventions. This book will be valuable resource for senior undergraduate and graduate students, researchers and other interested professionals or groups working in the interdisciplinary areas of microbiology and biotechnology.
