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This up-to-the-minute reference delineates - in a systematic fashion - the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products - covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

Pharmaceutical biotechnology. --- Parenteral solutions. --- Biotechnologie pharmaceutique --- Biopharmaceutics --- Parenteral therapy. --- Methods.

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Pharmaceutical biotechnology. --- Microbial contamination --- Clean rooms. --- Drugs --- Biotechnologie pharmaceutique --- Contamination --- Salles blanches --- Sterilization.

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Biotechnology --- Biotechnologie --- Pharmaceutical biotechnology --- Biotechnologie pharmaceutique --- Medical laws and legislation. --- Médecine --- Comparative law --- Droit comparé --- Law and legislation. --- Droit --- Pharmacology, Experimental --- Médicaments --- Drug approval --- Drug accessibility --- Essai clinique --- Autorisation de mise sur le marché --- Law and legislation --- Accessibilité

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This publication examines the innovation system in pharmaceutical biotechnology in eight OECD countries - Belgium, Finland, France, Germany, Japan, the Netherlands, Norway and Spain. The report summarises the results of in-depth studies, providing a comparative analysis of participating countries' performance in science and innovation in biopharmaceuticals. It highlights specific characteristics of the national biopharmaceutical innovation systems in terms of their international openness and the specific role of demand-side factors in the innovation process. Major systemic failures affecting the functioning of the biopharmaceutical innovation systems are identified. Based on rich evidence, the report draws policy recommendations to foster innovation in biopharmaceuticals advocating an integrated policy approach.

Biomedical technology. --- Biotechnology -- Research. --- Biotechnology. --- Pharmaceutical biotechnology -- Technological innovations. --- Research. --- Technology, Pharmaceutical. --- Pharmaceutical biotechnology --- Biotechnology --- Biological Science Disciplines --- Pharmacy --- Technology --- Investigative Techniques --- Science --- Health Occupations --- Natural Science Disciplines --- Technology, Industry, and Agriculture --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Disciplines and Occupations --- Technology, Industry, Agriculture --- Biomedical Technology --- Technology, Pharmaceutical --- Research --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Technological innovations --- Technological innovations. --- Biopharmaceutical technology --- Drugs --- Pharmaceutical technology --- Pharmaceutical biotechnology industry --- Biotechnologie pharmaceutique --- Industrie --- Innovations

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Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of monoclonal antibodies (mAbs) and other proteins.  In Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols, experts in the field provide readers with production and characterization protocols of glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. The volume is divided in four complementary parts dealing with glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complexes characterization, and PK/PD assays for therapeutic antibodies.  Written in the highly successful Methods in Molecular Biology™ series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.   Authoritative and cutting-edge, Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols serves as an ideal guide for scientists striving to push forward the exciting field of engineered biopharmaceuticals.

Pharmaceutical biotechnology --- Glycosylation --- Biopharmaceutics --- Glycoconjugates --- Investigative Techniques --- Pharmacology --- Carbohydrate Metabolism --- Antibodies --- Biological Science Disciplines --- Carbohydrates --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Biochemical Processes --- Immunoglobulins --- Natural Science Disciplines --- Biochemical Phenomena --- Chemicals and Drugs --- Immunoproteins --- Blood Proteins --- Chemical Phenomena --- Disciplines and Occupations --- Proteins --- Phenomena and Processes --- Amino Acids, Peptides, and Proteins --- Methods --- Glycoproteins --- Antibodies, Monoclonal --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Glycosylation. --- Pharmaceutical biotechnology. --- Biopharmaceutics. --- Biotechnologie pharmaceutique --- Biopharmacie --- therapeutic use. --- methods. --- Monoclonal Antibodies --- Protein Glycosylation --- Glycosylation, Protein --- Glycosylations --- Glycosylations, Protein --- Protein Glycosylations --- Glycoprotein --- Neoglycoproteins --- Methodological Studies --- Methodological Study --- Procedures --- Studies, Methodological --- Study, Methodological --- Method --- Procedure --- Gene Products, Protein --- Gene Proteins --- Protein Gene Products --- Proteins, Gene --- Chemical Phenomenon --- Chemical Process --- Physical Chemistry Phenomena --- Physical Chemistry Process --- Physicochemical Phenomenon --- Physicochemical Process --- Chemical Concepts --- Chemical Processes --- Physical Chemistry Concepts --- Physical Chemistry Processes --- Physicochemical Concepts --- Physicochemical Phenomena --- Physicochemical Processes --- Chemical Concept --- Chemistry Process, Physical --- Chemistry Processes, Physical --- Concept, Chemical --- Concept, Physical Chemistry --- Concept, Physicochemical --- Concepts, Chemical --- Concepts, Physical Chemistry --- Concepts, Physicochemical --- Phenomena, Chemical --- Phenomena, Physical Chemistry --- Phenomena, Physicochemical --- Phenomenon, Chemical --- Phenomenon, Physicochemical --- Physical Chemistry Concept --- Physicochemical Concept --- Process, Chemical --- Process, Physical Chemistry --- Process, Physicochemical --- Processes, Chemical --- Processes, Physical Chemistry --- Processes, Physicochemical --- Plasma Proteins --- Serum Proteins --- Proteins, Blood --- Proteins, Plasma --- Proteins, Serum --- Biochemical Concepts --- Biochemical Phenomenon --- Biochemical Process --- Phenomena, Biochemical --- Biochemical Concept --- Concept, Biochemical --- Concepts, Biochemical --- Phenomenon, Biochemical --- Process, Biochemical --- Processes, Biochemical --- Natural Sciences --- Physical Sciences --- Discipline, Natural Science --- Disciplines, Natural Science --- Natural Science --- Natural Science Discipline --- Physical Science --- Science, Natural --- Science, Physical --- Sciences, Natural --- Sciences, Physical --- Immunoglobulin --- Globulins, Immune --- Immune Globulins --- Carbohydrate --- Biologic Sciences --- Biological Science --- Science, Biological --- Sciences, Biological --- Biological Sciences --- Life Sciences --- Biologic Science --- Biological Science Discipline --- Discipline, Biological Science --- Disciplines, Biological Science --- Life Science --- Science Discipline, Biological --- Science Disciplines, Biological --- Science, Biologic --- Science, Life --- Sciences, Biologic --- Sciences, Life --- Metabolism, Carbohydrate --- Pharmacologies --- Pharmaceutical Preparations --- Investigative Technics --- Investigative Technic --- Investigative Technique --- Technic, Investigative --- Technics, Investigative --- Technique, Investigative --- Techniques, Investigative --- Glycation --- Biopharmaceutical technology --- Drugs --- blood --- metabolism --- pharmacology --- Biotechnology --- Medicine. --- Pharmacology. --- Biochemical engineering. --- Biomedicine. --- Pharmacology/Toxicology. --- Biochemical Engineering. --- Bio-process engineering --- Bioprocess engineering --- Biochemistry --- Chemical engineering --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Pharmacy --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Pathology --- Physicians --- Physiological effect --- Toxicology. --- Medicine --- Poisoning --- Poisons --- Toxicology