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Protein Drugs: Manufacturing TechnologiesPublished by: BCC Research Published: Jul. 1, 2000 - 299 Pages Table of ContentsIntroduction Goals And Objectives Of This Study Reasons For This Study And Its Contribution Audience For Report Scope And Content Of This Study Report Methodology And Information Sources Analyst Credentials And Related Reports BCC On-Line Services Summary Overview Key Definitions What Makes Protein Drugs Special Why Protein Drug Manufacturing Is Important Formulated Protein Drug Sales Formulation Sales Per Gram Of Protein Implications Of Sales Changes For Manufacturing Goods Flow In Protein Drug Manufacture Cost Of Manufacture Scientific Issues Affecting Choice Of Manufacturing Method In The Beginning Glycosylation And Folding Problems Herculean Hurdles Of Cell Culture Here Come Insects And Livestock Small Molecules To The Rescue? The Difference Between Lab And Commercial Production Bioprocess Scale-Up Changing The Manufacturing Process In Midstream Significance Of The Clinical Trials Barrier Technologies That May Limit The Future Of Protein Drugs Major Individual Protein Drugs Overview Analysis Of Protein Manufacturing Methods Summation Analysis Biological Methods Of Protein Production Regular Vs. Recombinant Biological Production Regular Biological Production Methods Recombinant Biological Production Methods Market Segmentation Of Recombinant Drugs Dollar Value Of Bulk Proteins Basis Of Forecasting Source Extraction Source Extraction Summary Basic Features Of Source Extraction Technology Human Sourcing Special Features Of Human-Sourcing Manufacture Protein Drugs Made By Human-Source Extraction Applications Of Human-Source Extraction Bulk Quantities Of Human-Source Drug Proteins Producers Of Human-Source Extracted Protein Drugs Animal Sourcing Special Features Of Animal Sourcing Manufacture Natural Animal Sourcing Protein Drugs Made By Natural Animal-Source Extraction Applications Of Natural Animal Sourcing Bulk Quantities Of Natural Animal-Source Drug Proteins Producers Of Natural Animal Source Extracted Protein Drugs Transgenic Animal Sourcing Technology For Animal Pharming Who's Doing What In Transgenic Animal Sourcing Assessment Of Transgenic Animal Sourcing's Prospects Plant Sourcing Natural Plant Sourcing Protein Drugs Made By Natural Plant Source Extraction Bulk Quantities Of Natural Plant Source Drug Proteins Transgenic Plant Sourcing Microbial Fermentation Microbial Fermentation Summary Regular Fermentation Basic Features Of Fermentation Technology Protein Drugs Made By Regular Fermentation Applications Of Regular Microbial Fermentation Bulk Quantities Of Regular Fermentation Drug Proteins Producers Of Regular Fermentation Protein Drugs Recombinant Microbial Fermentation Special Features Of Recombinant Microbial Fermentation Host Microbes For Recombinant Fermentation Drug Proteins Host Modifications For Improved Productivity Protein Drugs Made By Recombinant Microbial Fermentation Applications Of Recombinant Microbial Fermentation Bulk Quantities Of Recombinant Fermentation Drug Proteins Producers Of Recombinant Fermentation Protein Drugs Cell Culture Cell Culture Summary Regular Cell Culture Protein Drugs Made By Regular Cell Culture Applications Of Regular Cell Culture Bulk Quantities Of Proteins Made By Regular Cell Culture Producers Of Protein Drugs Made By Regular Cell Culture Recombinant Cell Culture Mammalian Cell Culture Technology Practical Perspective On The Development Of In Vitro Cell Culture Basic Features Of Mammalian Cell Culture Technology Host Cells For Recombinant Mammalian Cell Culture Protein Drugs Made By Recombinant Mammalian Cell Culture Applications Of Recombinant Mammalian Cell Culture Bulk Quantities Of Drug Proteins Made By R-Cell Culture . Producers Of Protein Drugs By Mammalian Cell Culture Recombinant Insect Cell Culture Synthesis Synthesis Summary Chemical Peptide Synthesis Technology Of Chemical Peptide Synthesis Peptide Drugs Made By Chemical Synthesis Bulk Quantities Of Drug Peptides Made By Chemical Synthesis Producers Of Chemically Synthesized Drug Proteins Prospects For Shortened Peptides Enzymatic Peptide Synthesis Technology Of Enzymatic Peptide Synthesis Peptide Drugs Made By Enzymatic Synthesis Post-Bulk Production Overview Of Post-Bulk Production Separation And Purification Purification Methods In Brief Important Issues In Purification Oncogenic Dna Contamination Viral Contamination Sterilization Upstream Solutions To Downstream Problems Chemical Modification Formulation Delivery Shares Of Bulk Proteins Injectable Delivery Injectable Protein Drug Volume Lyophilization Excipients For Injectable Protein Drugs Oral Delivery Topical Delivery Respiratory Delivery Transdermal Delivery Applications Applications Summary Blood Proteins Commercial Therapeutic Blood Proteins Blood Protein Manufacturing Methods Blood Protein Bulk Quantities New Blood Proteins Under Development Recombinant Albumin Factor Ixa Hemoglobin Protein C Blood Proteins Forecast Antibiotics Commercial Peptide Antibiotic Therapeutics Antibiotic Peptide Manufacturing Methods New Peptide Antibiotics Under Development Bactericidal/Permeability-Increasing Protein (Bpi) Magainin Peptidyl Mim Protegrin Ramoplanin Enzymes Commercial Therapeutic Enzymes Manufacture Of Therapeutic Enzymes Enzyme Bulk Protein Quantities New Therapeutic Enzymes Under Development Ananain And Comasain Transforming Growth Factor â2 (TgF...2) Alpha-L-Iduronidase á -Galactosidase (Human) Gelonin Glutamic Acid Decarboxylase Opa Anhydrase Ribonuclease Tpa Variants Enzymes Forecast Antibodies Commercial Therapeutic Antibodies Antibody Manufacture Polyclonal And Monoclonal Antibodies Bispecific Antibodies Antibody Bulk Quantities New Antibody Drugs Under Development Anti-Egfr Anti-Lymphoma Antibody (131i-Lym-1) Anti-Her2 (Bispecific) Anti-Cd11/Cd18 Integrin Anti-á 4...7 Integrin Receptor Anti-Cd52 Antibodies Forecast Hormones Protein Hormone Formulation Sales And Volume Protein Hormone Manufacturing Methods Hormone Bulk Protein Quantities New Hormones Under Development Amylin Extendin-4 Relaxin Bone Growth Factors Epidermal Growth Factor Fibroblast Growth Factor Nesp Hematopoietin Insulin-Like Growth Factor-1 Leptin Natriuretic Peptides Neural Growth Factors Parathyroid Hormone Thrombopoietin Thymosin Alpha-1 Hormones Forecast Enzyme Inhibitors Commercial Enzyme Inhibitor Therapeutics Manufacture Of Proteinaceous Enzyme Inhibitors Enzyme Inhibitor Bulk Quantities New Enzyme Inhibitors Under Development Angiostatin And Endostatin Bivalirudin Nematode Anticoagulant Proteins Enzyme Inhibitors Forecast Vaccines Commercial Proteinaceous Vaccines Vaccines Against Hiv And Cancer Manufacture Of Proteinaceous Vaccines Vaccine Bulk Protein Quantities Vaccines Forecast Lymphokines Lymphokine Formulation Sales And Volume Lymphokine Manufacturing Methods Lymphokine Bulk Quantities New Lymphokines Under Development Interleukin-4 Interleukin-6 Interleukin-10 Interleukin-12 Stem Cell Factor Myeloid Progenitor Inhibitory Factor-1 Macrophage Colony-Stimulating Factor Lymphokines Forecast Other Protein Drugs Not Previously Categorized Synopsis Of Sales, Volumes And Bulk Quantities Product Descriptions Botulinin Ctla4/Igg Fusion Protein Cd4/Igg Fusion Protein Collagen Lung Surfactant Protein Protamine Sulfate Il-4r Other Proteins Forecast Industry Overview Of The Protein Drug Industry Basic Elements Of Industry Structure Conventional Protein Drug Industry Biotechnology Protein Drug Industry Contract Manufacture Of Bulk Proteins Supportive Services To Protein Manufacture Role Of Technology Transfer In Commercialization Plant, Equipment And Raw Material Suppliers Regulation Of Protein Drugs And Their Manufacture Official And Off-Label Sales Patent Fights Over Manufacturing Methods Transkaryotic Vs. Amgen: Erythropoietin Genentech Vs. Novo Nordisk: Growth Hormone University Of California Vs. Eli Lilly: Insulin Biogen Vs. Chiron: B-Interferon Manufacturing Method As Indicator Of Market Share Are Generic Biopharmaceuticals In The Future? International Aspects Overview United States Western Europe Japan China Latin America Eastern Europe Rest Of The World Leading Market Participants Within Protein Drug Categories Protein Drug Company Profiles Alpharma A/S American Home Products Corp. Amgen Ares-Serono Group Abbott Laboratories Basf Ag Baxter Healthcare Corp Biogen, Inc Bioport Corporation Biospecifics Technologies Corp. Bristol-Myers Squibb Co Cantab Pharmaceuticals Chiron Corp Centocor (Now Part Of Johnson & Johnson) Creative Biomolecules, Inc Connetics Corporation Corixa Corporation Corvas International, Inc. Entremed Eli Lilly & Co Ferring Ab Fibrogen, Inc Genentech, Inc. Genzyme Corp. Genzyme Transgenics Genetics Institute, Inc. Immunex Interferon Sciences Immucell Corp. Immune Response Corporation Johnson & Johnson Inc Magainin Pharmaceuticals Inc Massachusetts Health Biologic Merck & Co., Inc Medimmune, Inc. Medeva Pharmaceuticals Inc. Medarex Nabi Novartis Pharma Ag Novo Nordisk A/S North American Vaccine, Inc. Organon International Bv Parkdale Pharmaceuticals Progenics Pharmaceuticals, Inc. Pasteur Merieux Connaught Pharmacia & Upjohn Ab Peptech Ltd. Pfizer Inc. Protein Design Labs Regeneron Pharmaceuticals, Inc. Ferring Ab Roche Holdings, Ltd. Rhone-Poulenc Rorer Inc. Sangstat Medical Corp. Sanofi S.A. Smithkline Beecham Plc Swiss Serum & Vaccine Institute (Berna) Unibios Unigene Laboratories, Inc. Xoma Corporation Appendix I: Methodology For Calculating Bulk Protein Quantities Appendix Ii: Contract Gmp Protein Manufacturers Appendix Iii: Periodical Sources Of Information Appendix Iv: Relevant Professional And Trade Organizations List Of Tables List Of Figures AbstractThe manufacture of protein drugs, being the interface between laboratory discovery and product sales, requires the solution of numerous problems. This new BCC study looks at all facets of protein drug manufacture, including lab vs. commercial production, choice of method, scale-up, upstream manipulation and more, and addresses important issues such as glycosylation, contamination and regulations. The report covers source extraction, fermentation, cell culture, chemical synthesis, and transgenic animals, as well as down-stream processing, including purification and formulation, and quantifying the input materials for protein drug production. Five-year market projections are given. Included in this report are relevant issues concerning technology transfer and patents, as well as profiles of established and emerging new protein drug companies.Get Full Details About This Report >> |
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