The Committee reports on general issues discussed and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

The use of biologics – drugs made from living organisms – has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.

Since Darwin, Biology has been framed on the idea of evolution by natural selection, which has profoundly influenced the scientific and philosophical comprehension of biological phenomena and of our place in Nature. This book argues that contemporary biology should progress towards and revolve around an even more fundamental idea, that of autonomy. Biological autonomy describes living organisms as organised systems, which are able to self-produce and self-maintain as integrated entities, to establish their own goals and norms, and to promote the conditions of their existence through their interactions with the environment. Topics covered in this book include organisation and biological emergence, organisms, agency, levels of autonomy, cognition, and a look at the historical dimension of autonomy. The current development of scientific investigations on autonomous organisation calls for a theoretical and philosophical analysis. This can contribute to the elaboration of an original understanding of life - including human life - on Earth, opening new perspectives and enabling fecund interactions with other existing theories and approaches. This book takes up the challenge.

The 75th meeting of the WHO Expert Committee on Biological Standardization was held from 4 to 8 April 2022 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvao Simão, Assistant Director-General, Access to Medicines and Health Products. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, developers of vaccines and other biological products and academia.

"The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 17 to 21 October 2011"--Introduction.

The use of biologics – drugs made from living organisms – has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.

​The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.

“Staggeringly good.” —Counterpunch A major new work, a hybrid of history, journalism, and memoir, about the modern Freedom of Information Act—FOIA—and the horrifying, decades-old government misdeeds that it is unable to demystify, from one of America's most celebrated writers Eight years ago, while investigating the possibility that the United States had used biological weapons in the Korean War, Nicholson Baker requested a series of Air Force documents from the early 1950s under the provisions of the Freedom of Information Act. Years went by, and he got no response. Rather than wait forever, Baker set out to keep a personal journal of what it feels like to try to write about major historical events in a world of pervasive redactions, witheld records, and glacially slow governmental responses. The result is one of the most original and daring works of nonfiction in recent memory, a singular and mesmerizing narrative that tunnels into the history of some of the darkest and most shameful plans and projects of the CIA, the Air Force, and the presidencies of Harry Truman and Dwight Eisenhower. In his lucid and unassuming style, Baker assembles what he learns, piece by piece, about Project Baseless, a crash Pentagon program begun in the early fifties that aimed to achieve "an Air Force-wide combat capability in biological and chemical warfare at the earliest possible date." Along the way, he unearths stories of balloons carrying crop disease, leaflet bombs filled with feathers, suicidal scientists, leaky centrifuges, paranoid political-warfare tacticians, insane experiments on animals and humans, weaponized ticks, ferocious propaganda battles with China, and cover and deception plans meant to trick the Kremlin into ramping up its germ-warfare program. At the same time, Baker tells the stories of the heroic journalists and lawyers who have devoted their energies to wresting documentary evidence from government repositories, and he shares anecdotes from his daily life in Maine feeding his dogs and watching the morning light gather on the horizon. The result is an astonishing and utterly disarming story about waiting, bureaucracy, the horrors of war, and, above all, the cruel secrets that the United States government seems determined to keep forever from its citizens.