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Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Antibodies, Monoclonal -- Analysis. --- Antibodies, Monoclonal -- Pharmacokinetics. --- Biotechnology -- Methods. --- Monoclonal antibodies. --- Monoclonal antibodies --- Biotechnology --- Pharmacokinetics --- Antibodies, Monoclonal --- Methods --- Investigative Techniques --- Antibodies --- Kinetics --- Technology --- Biological Science Disciplines --- Biochemical Phenomena --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Technology, Industry, and Agriculture --- Immunoglobulins --- Natural Science Disciplines --- Disciplines and Occupations --- Serum Globulins --- Chemical Phenomena --- Immunoproteins --- Technology, Industry, Agriculture --- Phenomena and Processes --- Globulins --- Blood Proteins --- Proteins --- Amino Acids, Peptides, and Proteins --- Chemicals and Drugs --- Neurology --- Microbiology & Immunology --- Biology --- Medicine --- Health & Biological Sciences --- Immunology. --- Immunobiology --- Monoclonal immunoglobulins --- Medicine. --- Neurosciences. --- Pharmacology. --- Biomedicine. --- Pharmacology/Toxicology. --- Life sciences --- Serology --- Molecular cloning --- Toxicology. --- Chemicals --- Pharmacology --- Poisoning --- Poisons --- Neural sciences --- Neurological sciences --- Neuroscience --- Medical sciences --- Nervous system --- Toxicology --- Drug effects --- Medical pharmacology --- Chemotherapy --- Drugs --- Pharmacy --- Physiological effect

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Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent. This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophy.

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Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

History of human medicine --- Pharmacology. Therapy --- Neuropathology --- neurologie --- farmacologie --- toxicologie