Evolving Scientific And Regulatory Perspectives On Cell Substrates For Vaccine Development

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Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development

Author : Fred Brown
Publisher :
ISBN 13 :
Total Pages : 564 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development by : Fred Brown

Download or read book Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development written by Fred Brown and published by . This book was released on 2001 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: In September 1999, the cell substrate workshop entitled 'Evolution of Cell Substrates Used in the Manufacture of Biologicals' was held as a means to consider in depth the issues raised by the need to use neoplastic, i.e. continuous, cells as substrates for viral vaccine manufacture. Workshop goals included identifying the risks and concerns associated with the use of neoplastic cell substrates and determining the manner in which these could be assessed. Volume 106 of Developments in Biologicals presents the edited proceedings of this workshop. It is the latest in a series of monographs that go back to 1967 and record the proceedings of meetings devoted to issues concerning the use of cells cultured in vitro as substrates for the manufacture of viral vaccines. The current workshop covered the following: - a review of the history of cell substrate use in the production of biologicals - scientific issues related to the development of the neoplastic state and tumorigenicity - viral-viral and viral-cell interactions - the oncogenic potential of residual cell-substrate DNA - adventitious agent testing - ways to generate immortalized cells in vitro The purpose of these discussions was to build on the concepts and precedents for the scientifically based, regulatory management of viral vaccines documented in the earlier monographs. It is the hope of the meeting organizers and sponsors that this volume will assist in generating confidence among vaccine developers, manufacturers, regulatory agencies and the general public that the use of neoplastic cell substrates, within an effective, reasoned, regulatory approach, is feasible.

The Virus and the Vaccine

Author : Debbie Bookchin
Publisher : Macmillan + ORM
ISBN 13 : 1466848995
Total Pages : 541 pages
Book Rating : 4.4/5 (668 download)

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Book Synopsis The Virus and the Vaccine by : Debbie Bookchin

Download or read book The Virus and the Vaccine written by Debbie Bookchin and published by Macmillan + ORM. This book was released on 2013-07-02 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Jonas Salk's polio vaccine has taken on an almost legendary quality as a medical miracle, for it largely eradicated one of the most feared diseases of the 20th century. But the story of the vaccine has a dark side, one that has never been fully told before... Between 1954 and 1963, close to 98 million Americans received polio vaccinations contaminated with a carcinogenic monkey virus, now known as SV40. A concerted government effort downplayed the incident, and it was generally accepted that although oncogenic to laboratory animals, SV40 was harmless to humans. But now SV40 in showing up in human cancers, and prominent researchers are demanding a serious public health response to this forgotten polio vaccine contaminant. A gripping medical detective story, The Virus and the Vaccine raises major questions about vaccine policy.

Cellular Ageing and Replicative Senescence

Author : Suresh I.S. Rattan
Publisher : Springer
ISBN 13 : 3319262394
Total Pages : 364 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Cellular Ageing and Replicative Senescence by : Suresh I.S. Rattan

Download or read book Cellular Ageing and Replicative Senescence written by Suresh I.S. Rattan and published by Springer. This book was released on 2016-05-09 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the origins and subsequent history of research results in which attempts have been made to clarify issues related to cellular ageing, senescence, and age-related pathologies including cancer. Cellular Ageing and Replicative Senescence revisits more than fifty-five years of research based on the discovery that cultured normal cells are mortal and the interpretation that this phenomenon is associated with the origins of ageing. The mortality of normal cells and the immortality of cancer cells were also reported to have in vivo counterparts. Thus began the field of cytogerontology. Cellular Ageing and Replicative Senescence is organized into five sections: history and origins; serial passaging and progressive ageing; cell cycle arrest and senescence; system modulation; and recapitulation and future expectations. These issues are discussed by leading thinkers and researchers in biogerontology and cytogerontology. This collection of articles provides state-of-the-art information, and will encourage students, teachers, health care professionals and others interested in the biology of ageing to explore the fascinating and challenging question of why and how our cells age, and what can and cannot be done about it.

Vaccines and Diagnostics for Transboundary Animal Diseases

Author : J.A. Roth
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318023655
Total Pages : 231 pages
Book Rating : 4.3/5 (18 download)

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Book Synopsis Vaccines and Diagnostics for Transboundary Animal Diseases by : J.A. Roth

Download or read book Vaccines and Diagnostics for Transboundary Animal Diseases written by J.A. Roth and published by Karger Medical and Scientific Publishers. This book was released on 2013-04-18 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transboundary animal diseases (TADs) are a major threat to livestock. They are highly contagious or transmissible, and they have the potential to cause high morbidity and mortality in both susceptible animal populations and humans. In addition, not only are TADs detrimental to national economies, they are also a serious threat to world food security. This volume presents the proceedings of an international workshop on Vaccines and Diagnostics for Transboundary Animal Diseases that was held in Ames (Iowa, USA) in 2012. Experts and scientists from academia, industry and government reviewed the current status of vaccines and diagnostics for high priority TADs, decision-making and regulatory processes for veterinary biologics, and the roles and responsibilities of government agencies. The discussions also addressed achievements and gaps in vaccine and diagnostics development for 11 important TADs as well as the translation of research findings into licensed novel vaccines and diagnostics for high-priority TADs.

Animal Genomics for Animal Health

Author : Marie-Hélène Pinard
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805586191
Total Pages : 455 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Animal Genomics for Animal Health by : Marie-Hélène Pinard

Download or read book Animal Genomics for Animal Health written by Marie-Hélène Pinard and published by Karger Medical and Scientific Publishers. This book was released on 2008-01-01 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: "It includes a review of the state of the art in animal genomics and its applications to animal health. The contributions describe the new tools available, such as HapMaps for chicken and cattle, and show how the understanding of gene structure and function can be successfully applied to delineate the molecular mechanisms of disease and determine complex phenotypes associated with health traits. A critical evaluation of future needs and future applications of animal genomics is also presented. The integration of animal genomics in animal health research is likely to revolutionize the way scientists approach the challenges of discovering highly effective drugs and vaccines for animal diseases."--BOOK JACKET.

Animal Biotechnology

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309084393
Total Pages : 201 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Animal Biotechnology by : National Research Council

Download or read book Animal Biotechnology written by National Research Council and published by National Academies Press. This book was released on 2002-12-29 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.

Advances in Transfusion Safety

Author : Fred Brown
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Advances in Transfusion Safety by : Fred Brown

Download or read book Advances in Transfusion Safety written by Fred Brown and published by S. Karger AG (Switzerland). This book was released on 2002 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This symposium highlighted the principle that blood transfusion is an entire process and not a single product, requiring haemovigilance and quality assurance from 'vein' to 'vein'. The prevention of contaminated blood and blood products was a major focus. Today's blood services provide remarkably safe therapeutic products that are virtually devoid of transmissible enveloped viruses. However, the risk of bacterial infection, especially in platelet concentrates, is probably underrated and may warrant routine sterility testing or universal pathogen inactivation without incurring the loss of the therapeutic functions of blood products. The unknown risk of prion transmission requires precautionary measures, including leukocyte depletion that may otherwise be beneficial in some patients. The methods for universal pathogen inactivation continue to evolve with some of them due to be licensed for use in the treatment of blood products. Stem cell transplantation portends a new chapter in haemotherapy. However, the question that no one has seriously addressed is the threshold of benefits commensurate with escalating costs that could lead to the unavailability of blood transfusion as an affordable therapy. This publication provides state-of-the-art reviews of hot topics to transfusionists, haematologists, virologists, and scientists in the plasma industry and regulatory authorities, and illustrates how the International Association for Biologicals continues to serve contemporary issues in science and society.

Biological Safety

Author : Dawn P. Wooley
Publisher : John Wiley & Sons
ISBN 13 : 1683673131
Total Pages : 953 pages
Book Rating : 4.6/5 (836 download)

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Book Synopsis Biological Safety by : Dawn P. Wooley

Download or read book Biological Safety written by Dawn P. Wooley and published by John Wiley & Sons. This book was released on 2017-02-01 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.

Medicines from Animal Cell Culture

Author : Glyn N. Stacey
Publisher : John Wiley & Sons
ISBN 13 : 9780470723784
Total Pages : 696 pages
Book Rating : 4.7/5 (237 download)

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Book Synopsis Medicines from Animal Cell Culture by : Glyn N. Stacey

Download or read book Medicines from Animal Cell Culture written by Glyn N. Stacey and published by John Wiley & Sons. This book was released on 2007-06-29 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Information Resources in Toxicology

Author : P.J. Bert Hakkinen
Publisher : Academic Press
ISBN 13 : 9780080920030
Total Pages : 1552 pages
Book Rating : 4.9/5 (2 download)

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Book Synopsis Information Resources in Toxicology by : P.J. Bert Hakkinen

Download or read book Information Resources in Toxicology written by P.J. Bert Hakkinen and published by Academic Press. This book was released on 2009-08-19 with total page 1552 pages. Available in PDF, EPUB and Kindle. Book excerpt: This latest version of Information Resources in Toxicology (IRT) continues a tradition established in 1982 with the publication of the first edition in presenting an extensive itemization, review, and commentary on the information infrastructure of the field. This book is a unique wide-ranging, international, annotated bibliography and compendium of major resources in toxicology and allied fields such as environmental and occupational health, chemical safety, and risk assessment. Thoroughly updated, the current edition analyzes technological changes and is rife with online tools and links to Web sites. IRT-IV is highly structured, providing easy access to its information. Among the “hot topics covered are Disaster Preparedness and Management, Nanotechnology, Omics, the Precautionary Principle, Risk Assessment, and Biological, Chemical and Radioactive Terrorism and Warfare are among the designated. • International in scope, with contributions from over 30 countries • Numerous key references and relevant Web links • Concise narratives about toxicologic sub-disciplines • Valuable appendices such as the IUPAC Glossary of Terms in Toxicology • Authored by experts in their respective sub-disciplines within toxicology

DNA Viruses

Author : Paul M. Lieberman
Publisher : Springer Science & Business Media
ISBN 13 : 159259848X
Total Pages : 486 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis DNA Viruses by : Paul M. Lieberman

Download or read book DNA Viruses written by Paul M. Lieberman and published by Springer Science & Business Media. This book was released on 2008-02-04 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: A compendium of readily reproducible and novel methods to manipulate DNA viruses and characterize their varied biological properties. The authors emphasize techniques for viral detection and genetics, but also include methods for structure determination, gene expression, replication, pathogenesis, complex cellular models, recombinant genetics, and computational/systems approaches. Wide-ranging and highly practical, DNA Viruses: Methods and Protocols will stimulate new directions in virology research with its novel strategies for engineering viral vectors in gene therapy, and its advanced approaches for detecting viruses in human disease.

Vaccine Cell Substrates 2004

Author : Rebecca Sheets
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 380 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Vaccine Cell Substrates 2004 by : Rebecca Sheets

Download or read book Vaccine Cell Substrates 2004 written by Rebecca Sheets and published by S. Karger AG (Switzerland). This book was released on 2006 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication comprises the proceedings of the Vaccine Cell Substrates 2004 conference. The purpose of this conference was to review current data and progress in the field of cell substrates, discuss the continued use of existing tests and the appropriateness of new ones at this time, and develop consensus recommendations on how to address these issues, by either recommending implementation or identifying research gaps that preclude decision-making. Scientific topics covered oncogenicity of cellular components, both latent viruses and cellular DNA, viral adventitious agent test methods, level of assurance provided by the current tests, bovine (and porcine) viruses in (primarily) bovine-derived raw materials, and bovine spongiform encephalopathy agents as potential contaminants of cell substrates. Also presented were tests that ensure the safety and quality of novel vaccine cell substrates for investigational vaccine production. Academia, regulators, the vaccine industry and the testing industry developing, regulating or testing viral vaccines will greatly benefit from the wealth of new findings.

The Vaccine Book

Author : Barry R. Bloom
Publisher : Academic Press
ISBN 13 : 0121072584
Total Pages : 470 pages
Book Rating : 4.1/5 (21 download)

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Book Synopsis The Vaccine Book by : Barry R. Bloom

Download or read book The Vaccine Book written by Barry R. Bloom and published by Academic Press. This book was released on 2003 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: A definitive and readable reference guide to the world of vaccines! The Vaccine Book provides concrete information on the current and future world 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. The Vaccine Book is designed to increase the understanding of vaccines for students, researchers, public health officials, and all others working to address such challenges. Topics unique to this book: * Ethics * Economics * Diseases that could be prevented * Clinical trial designs * Ideas about the future of vaccines * Challenges facing research scientists in the vaccine area * Burden of vaccine-preventable illness and the impact of vaccines * Scientific obstacles to be overcome by existing and new vaccines * Basic mechanisms of host immunity and pathogen interaction with host tissues * New approaches to future vaccines against challenging diseases * Real and perceived safety issues which dominate vaccine development and vaccination policies * Microbial pathogenesis as a basis for vaccine design * Planning vaccine trials * Introducing new vaccines into the healthcare system * Future challenges for vaccines and immunizations

OIE/FAO International Scientific Conference on Avian Influenza

Author : Alejandro Schudel
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 292 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis OIE/FAO International Scientific Conference on Avian Influenza by : Alejandro Schudel

Download or read book OIE/FAO International Scientific Conference on Avian Influenza written by Alejandro Schudel and published by S. Karger AG (Switzerland). This book was released on 2006 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph comprises the proceedings of the International Conference on Avian Influenza held in Paris, France, in April 2005. Discussed were new scientific discoveries in the domain of avian influenza (AI), with special emphasis on the highly pathogenic avian influenza (HPAI). It provides important up-to-date information on the virology, epidemiology and molecular biology as well as the history of episodes of avian influenza in different parts of the world and their consequences. The publication aims at making recommendations to compare and improve the international procedures and standards related to the identification, prevention, control and elimination of AI epizootics as they are a threat to the livelihood of farmers, especially in developing countries, to public health as well as to national economies. Chief veterinary officers, animal health regulatory officials, veterinarians, poultry-raising associations, consumer associations, specialised journalists and all those who need to understand and control AI episodes will benefit from reading this book.

New Diagnostic Technology

Author : Philippe Vannier
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 356 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis New Diagnostic Technology by : Philippe Vannier

Download or read book New Diagnostic Technology written by Philippe Vannier and published by S. Karger AG (Switzerland). This book was released on 2006 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technological advances have resulted in the development of several new biochemistry-based test procedures such as DNA micro-arrays, rapid sequencing and multiple applications of polymerase chain reaction. The limitations of such tests and the problems of standardization and validation related to their use for the detection of agents and toxins, diagnosis of human and animal diseases, and quality control of human and veterinary biological products must be considered. Practical examples of the use of these new technologies, but also the difficulties, limits and uncertainties encountered in their application need to be shared. This volume presents the proceedings of a conference in Saint-Malo, France, held to facilitate discussion between government authorities, industry, scientists and other users of these new techniques. Information on the principles of these novel methods, the need for standardization and validation, applications in diagnosis and surveillance, certainties and uncertainties in agent or toxin identification as well as examples of quality control of human and veterinary biological products were addressed. Conclusions and recommendations concerning the development and standardization of these new technologies were developed by the participants and are published in these proceedings. Professionals involved in biological standardization, diagnosis, and human and animal health programs should find this to be a very valuable book.

Vaccination

Author : Betty Dodet
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 212 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Vaccination by : Betty Dodet

Download or read book Vaccination written by Betty Dodet and published by S. Karger AG (Switzerland). This book was released on 2007 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The international community is confronted with a crisis caused by the unprecedented global spread of highly pathogenic avian influenza and its consequent scientific, economic, political, social and ethical challenges. Control strategies based only on the application of sanitary measures and the culling of animals that are infected or suspected of being infected have proven insufficient to avoid the propagation of infection. The OIE, together with the FAO, recommend the strategic use of poultry vaccination in certain situations as part of an overall integrated strategy to control the disease. This volume presents the proceedings of a scientific conference co-organized by the OIE, FAO and the Istituto Zooprofilattico Sperimentale delle Venezie with the support of the European Commission. The conference brought together scientists, representatives of government authorities, industry and other stakeholders to review current methods and recent experiences in the use of vaccination as a means to control and prevent losses due to avian influenza. They also scrutinized international standards and regulations for vaccination and considered the implementation of vaccination programmes. The proceedings include presentations on the experiences made in various parts of the world and the challenges and constraints faced by developing countries in implementing effective vaccination campaigns. Other contributions provide guidance to decision makers concerned with planning vaccination campaigns and up-to-date information on developments in avian influenza vaccines, their efficacy, their performance in different avian species and on strategies of differentiating infected from vaccinated animals as well as their application.

Advances in Transfusion Safety

Author : Girish N. Vyas
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 244 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Advances in Transfusion Safety by : Girish N. Vyas

Download or read book Advances in Transfusion Safety written by Girish N. Vyas and published by S. Karger AG (Switzerland). This book was released on 2005 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transfusion medicine is an exciting and constantly advancing science. As new knowledge and cost-efficient safety technologies continue to emerge, the dichotomy between blood collection/transfusion practices and standards in developed and less-developed countries begins to blur. This publication reflects the state-of-the-art lectures and discussions of the Third IABs Symposium on Advances in Transfusion Safety, focusing on the current practice, successes and failures in applying these modern advances in the less-developed areas of the world. The review of TSE agents and their resulting impact on the safety of the worldwide blood supply is of particular interest. Some of the world's leading experts in transfusion medicine present the cutting-edge advances in blood screening tests, discussing the challenges of global harmonization and the complex but critical movement toward evidence-based transfusion practices. Transfusion medicine specialists, blood bankers and blood donor recruiters, policy makers, infectious disease and public health specialists will greatly benefit from this timely publication.