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Protein Therapeutics Production: Large-scale Mammalian Cell CulturePublished by: Drug and Market Development Publishing Published: Dec. 5, 2005 - 75 Pages Table of ContentsChapter 1: Overview of Large-Scale Cell Culture Two Decades of Experience Chapter 2: Mammalian Cells Cell Line Generation Cell Line Selection Post Translational Modifications (PTMs) Cell Line Types and Characteristics Chinese Hamster Ovary PER.C6 NS0 BHK Hybridomas Insect Cell Culture Choice of Cell Line Blood Factors Antibodies Enzymes Hormones Chapter 3: Cell Line Engineering Vectors and Host Cells Cell Culture Health Bacterial and Fungal Mycoplasmas Viral Chapter 4: Cell Culture Methods and Design Small Scale Large Scale Culture Modeling Media Selection Bioreactor Design Physical Configurations Batch and Fed-batch Perfusion Centrifugal Bioreactor Process Monitoring and Control Chapter 5: Product Characterization Process Impact on Product Species Variation Regulatory Environment Chapter 6: References TABLE OF EXHIBITS Exhibit 1.1 Technologies Used to Prepare Commercial Products Exhibit 1.2 Major Licensed Recombinant Therapeutics Expressed by Mammalian Cell Lines Exhibit 2.1 Typical Steps in the Creation of a Mammalian Cell Line and Process Design Exhibit 2.2 Example Antibody Products (Adapted from BioPharm International, 2004) Exhibit 3.1 Contribution of Various Stages to the Time and Titer During Cell Line Development Exhibit 3.2 Examples of Viral Contamination of Commercial Cell Cultures Exhibit 3.3 Viral Tests Exhibit 4.1 Comparison of in vivo and in vitro Systems for the Production of Monoclonal Antibodies Exhibit 4.2 Comparison of Recombinant Factor VIII Products: Presence of Humanand/ or Albumin-Derived Plasma/albumin Exhibit 4.3 Comparison of Recombinant Factor VIII Products AbstractD&MD's Protein Therapeutics Production: Large-scale Mammalian Cell Culture provides an introduction and overview of current manufacturing practices associated with large scale mammalian cell culture. The focus is on the use of large scale mammalian cell culture systems. The industry, which began in the late 1980s from the utilization of recombinant DNA technology and cell hybridization, is now a significant production process of the biopharmaceutical industry. As of 2003 the biopharmaceutical market represented over $40 billion in sales annually contributed by over 90 products approved for 130 disease indications. With over 350 additional products in clinical development and approximately 10 new products approved per year, growth for this market is expected to continue at >20% annually. Today, a quarter of all new drug approvals are for biopharmaceuticals. The approved drugs include hormones, blood factors, thrombolytics, vaccines, interferons, monoclonal antibodies (MAb), and therapeutic enzymes. The primary method of producing many of these biopharmaceuticals is mammalian cell culture. This publication presents an overview of current techniques used for the production of protein therapeutics.Get Full Details About This Report >> |
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