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The untold story of monoclonal antibodies-the molecular heroes of biotechnology that revolutionized the diagnosis and treatment of more than fifty major diseases This book is the first to tell the extraordinary yet unheralded history of monoclonal antibodies. Often referred to as Mabs, they are unfamiliar to most nonscientists, yet these microscopic protein molecules are everywhere, quietly shaping our lives and healthcare. Discovered in the mid-1970s in the laboratory where Watson and Crick had earlier unveiled the structure of DNA, Mabs have radically changed understandings of the pathways of disease. They have enabled faster, cheaper, and more accurate clinical diagnostic testing on a vast scale. And they have played a fundamental role in pharmaceutical innovation, leading to such developments as recombinant interferon and insulin, and personalized drug therapies such as Herceptin. Today Mabs constitute six of the world's top ten blockbuster drugs and make up a third of new introduced treatments. Lara V. Marks recounts the risks and opposition that a daring handful of individuals faced while discovering and developing Mabs, and she addresses the related scientific, medical, technological, business, and social challenges that arose. She offers a saga of entrepreneurs whose persistence and creativity ultimately changed the healthcare landscape and brought untold relief to millions of patients. Even so, as Marks shows, controversies over Mabs remain, and she examines current debates over the costs and effectiveness of these innovative drugs.

Monoclonal antibodies --- Antibodies, Monoclonal --- Monoclonal immunoglobulins --- Immunoglobulins --- Molecular cloning --- Therapeutic use. --- Therapeutic use --- History.

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This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates,  PEGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process validation, regulatory submission and launch of a stable, safe and effective product. Lyophilized Biologics and Vaccines: Modality-Based Approaches serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment in frozen systems, buffer stabilization, instrumental analysis and controlled ice nucleation technology Details product development strategies based on diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Recent updates on quality-by-design and process analytical technology approaches, illustrated by case studies and FDA perspective Provides the latest account of alternate drying technologies including spray drying and bulk freeze-drying Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals.  Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development and commercial manufacturing.   Dushyant B. Varshney, Ph.D., has made significant contributions in manufacturing science and technology, due diligence, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccines and small molecules. He is currently a Director of Manufacturing Assessment, MS&T at Hospira Inc.   Manmohan Singh, Ph.D., is a well-known expert in the area of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last 20 years. He is currently the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC.

Biomedicine. --- Vaccine. --- Antibodies. --- Pharmaceutical Sciences/Technology. --- Medicine. --- Monoclonal antibodies. --- Vaccines. --- Pharmaceutical technology. --- Médecine --- Anticorps monoclonaux --- Vaccins --- Techniques pharmaceutiques --- Biology --- Health & Biological Sciences --- Microbiology & Immunology --- Pharmacy, Therapeutics, & Pharmacology --- Freeze-drying. --- Frozen drugs. --- Cryopharmacy --- Drugs --- Drugs, Frozen --- Freezing of drugs --- Lyophilization --- Freezing --- Cryobiology --- Drying apparatus --- Refrigeration and refrigerating machinery --- Sublimation (Chemistry) --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Antibodies, Monoclonal --- Monoclonal immunoglobulins --- Immunoglobulins --- Molecular cloning --- Biologicals --- Antibodies --- Immune globulins --- Immune serum globulin --- Blood proteins --- Globulins --- Plasma cells --- Antibody diversity --- Antigens --- Bacterial immunoglobulin-binding proteins

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This volume examines all facets of the complex biology of Immunoglobulin E (IgE) antibodies, which play an essential role in the pathophysiology of allergic diseases and immunity to parasites. It highlights the unique mechanisms involved in the regulation of IgE production at both the molecular and cellular level. Furthermore, it discusses in detail novel findings on how the affinity, specificity and cross-reactivity of IgE can fine-tune mast cell responses to allergens. The book also explores the beneficial roles of IgE antibodies in immunity to helminthes and protection against tumors, and how the properties of IgE-mediated immunity are employed in the development of IgE therapeutic antibodies. All chapters were written by respected experts in their fields and will appeal to scientists and clinicians alike.

Biomedicine. --- Antibodies. --- Molecular Medicine. --- Allergology. --- Parasitology. --- Medicine. --- Monoclonal antibodies. --- Medical parasitology. --- Allergy. --- Médecine --- Anticorps monoclonaux --- Parasitologie médicale --- Allergie --- Biology --- Health & Biological Sciences --- Microbiology & Immunology --- Immunoglobulin E --- Immunoglobulin G --- Receptors. --- Analysis. --- IgE --- IgG --- Molecular biology. --- Allergic diseases --- Allergies --- Hypersensitivity --- Hypersensitivity, Immediate --- Immediate allergy --- Immediate hypersensitivity --- Immunologic diseases --- Molecular biochemistry --- Molecular biophysics --- Biochemistry --- Biophysics --- Biomolecules --- Systems biology --- Antibodies --- Immune globulins --- Immune serum globulin --- Blood proteins --- Globulins --- Plasma cells --- Antibody diversity --- Antigens --- Bacterial immunoglobulin-binding proteins --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Physicians --- Immunoglobulins --- Allergy --- Anti-immunoglobulin autoantibodies --- Human beings --- Human parasitology --- Parasitology --- Parasitic diseases --- Antibodies, Monoclonal --- Monoclonal immunoglobulins --- Molecular cloning --- Parasites --- Health Workforce --- Immunospecificity. --- Medicine --- Adaptive Immunity. --- Biomedical Research. --- Research. --- Biological research --- Biomedical research --- Immunological specifics --- Serological specificity --- Specificity (Immunology) --- Antigenic determinants --- Binding sites (Biochemistry) --- Immune recognition