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This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.
Offers a new understanding of the relationships between litigation strategies, growing private funding and European human rights justice.
Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.
The preeminent doctor and bioethicist Ezekiel Emanuel is repeatedly asked one question: Which country has the best healthcare? He set off to find an answer. The US spends more than any other nation, nearly $4 trillion, on healthcare. Yet, for all that expense, the US is not ranked #1 -- not even close. In Which Country Has the World's Best Healthcare? Ezekiel Emanuel profiles eleven of the world's healthcare systems in pursuit of the best or at least where excellence can be found. Using a unique comparative structure, the book allows healthcare professionals, patients, and policymakers alike to know which systems perform well, and why, and which face endemic problems. From Taiwan to Germany, Australia to Switzerland, the most inventive healthcare providers tackle a global set of challenges -- in pursuit of the best healthcare in the world.
Management Information Systems provides comprehensive and integrative coverage of essential new technologies, information system applications, and their impact on business models and managerial decision-making in an exciting and interactive manner. The twelfth edition focuses on the major changes that have been made in information technology over the past two years, and includes new opening, closing, and Interactive Session cases.
The human body contains many organs, and every organ is made up of countless tiny cells-cells that are "born" specific to each organ. These Normal Cells understand from the start the job they need to do to keep their home organ healthy.Little Nano is a special kind of cell, a cell with an evolving story: she is a Stem Cell. Born in the Bone Marrow, Nano will eventually become a Normal Cell assigned to one specific organ. But what organ will she eventually call home?To prepare for this big decision, the little Stem Cell will go exploring and get to know the organs of the human body. Ready to meet Nano? She's about to begin her wonderful journey!
NAMED A BEST BOOK OF THE YEAR 2023 BY THE NEW YORKER NEW YORK TIMES EDITOR'S CHOICE SELECTION "A propulsive, utterly engrossing history... None of it is simple and all of it is captivating."—The New York Times "Mapping the Darkness offers two narratives at once: a sweeping journey of discovery about dreams, sleep and the terra incognita of unconsciousness; and a wake-up call about the dangers of chronic exhaustion. It’s time, Mr. Miller tells us, to take our sleep back."—The Wall Street Journal From award-winning journalist Kenneth Miller comes the definitive story of the scientists who set out to answer two questions: “Why do we sleep?” and "How can we sleep better?” A century ago, sleep was considered a state of nothingness—even a primitive habit that we could learn to overcome. Then, an immigrant scientist and his assistant spent a month in the depths of a Kentucky cave, making nationwide headlines and thrusting sleep science to the forefront of our consciousness. In the 1920s, Nathaniel Kleitman founded the world’s first dedicated sleep lab at the University of Chicago, where he subjected research participants (including himself) to a dizzying array of tests and tortures. But the tipping point came in 1938, when his cave experiment awakened the general public to the unknown—and vital—world of sleep. Kleitman went on to mentor the talented but troubled Eugene Aserinsky, whose discovery of REM sleep revealed the astonishing activity of the dreaming brain, and William Dement, a jazz-bass playing revolutionary who became known as the father of sleep medicine. Dement, in turn, mentored the brilliant maverick Mary Carskadon, who uncovered an epidemic of sleep deprivation among teenagers, and launched a global movement to fight it. Award-winning journalist Kenneth Miller weaves together science and history to tell the story of four outsider scientists who took sleep science from fringe discipline to mainstream obsession through spectacular experiments, technological innovation, and single-minded commitment. Readers will walk away with a comprehensive understanding of sleep and why it affects so much of our lives.