D&MD s Large Scale Mammalian Cell Culture Report presents an analysis of currently used techniques in the production of marketed products by mammalian cell culture systems. It presents the latest indications of productivity levels being achieved as well as the latest information on cell culture media, disposable technology, competitor technologies, and capacity issues.
The Report includes up to date figures of the revenue that products generated by this technology achieve and the companies that market them. Results of an industry technology survey provide primary research on the current opinions of industry practitioners.
TABLE OF CONTENTS
Chapter 1: Executive Summary
Chapter 2: Overview of Large-Scale Cell Culture
- Two Decades of Experience
- Scienti.c Benchmarks
Chapter 3: Mammalian Cell Culture
- Cell Line Types
- Cell Line Selection
- Post Translational Modi.cations (PTMs)
- Cell Line Types
- Chinese Hamster Ovary
- PER.C6
- NS0
- BHK
- Hybridomas
- Insect Cell Culture
- Choice of Cell Line
- Blood Factors
- Antibodies
- Hormones
Chapter 4: Cell Line Engineering
- Vectors and Host Cells
- Cell Culture Health
- Bacterial and Fungal
- Mycoplasmas
- Viral
Chapter 5: Cell Culture Methods and Design
- Small Scale
- Large Scale
- Culture Modeling
- Media Selection
- Bioreactor Design
- Physical Con.gurations
- Batch and Fed-batch
- Perfusion
- Centrifugal Bioreactor
- Process Monitoring and Control
Chapter 6: Product Characterization
- Process Impact on Product
- Species Variation
- Regulatory Environment
Chapter 7: Industry Outlook
- Generics
- Competing Technologies
- Microbial
- Transgenic Technologies
- Animals
- Plants and Plant Cell Cultures
- Gene Therapy
- Antisense Oligonucleotides
- Future Developments
- Biopharmaceutical Manufacturing Facilities
- Culture Yield Improvements
Chapter 8: Company pro.les
- Abbott Laboratories
- Amgen
- Biosynergy (Europe) Ltd
- Boeheringer-Ingelheim
- Cambrex Biopharmaceutical Services
- Diosynth Biotechnology
- DSM Biologics
- GlaxoSmithKline Biopharmaceuticals
- HyClone
- JRH Biosciences
- Lonza
- New Brunswick Scienti.c
- SAFC
- Wave Biotechnology
- Xcellerex
Chapter 9: End-user Market Survey
Chapter 10: References
TABLE OF EXHIBITS
- Exhibit 1.1 Epogen Sales
- Exhibit 1.2 Highest Grossing Biologics
- Exhibit 2.1 Technologies Used to Prepare Commercial Products
- Exhibit 2.2 Major Licensed Recombinant Therapeutics Expressed by
- Mammalian Cell Lines
- Exhibit 3.1 Typical Steps in the Creation of a Mammalian Cell Line and Process Design
- Exhibit 3.2 Probability of Success in Clinical Trials
- Exhibit 3.3 Current Antibody Products (adapted from BioPharm International, 2004)
- Exhibit 3.4 Yearly Revenues Earned and Forecasted for Antibody Therapeutics
- Exhibit 4.1 Contribution of Various Stages to the time and Titer during
- Cell Line Development
- Exhibit 4.2 Examples of Viral Contamination of Commercial Cell Cultures
- Exhibit 4.3 Viral Tests
- Exhibit 5.1 Comparison of in vivo and in vitro Systems for the Production of
- Monoclonal Antibodies
- Exhibit 5.2 Comparison of Recombinant Factor VIII Products: Presence of Human-
- and/or Albumin-Derived Plasma/albumin
- Exhibit 5.3 Comparison of Recombinant Factor VIII Products
- Exhibit 7.1 Biopharmaceutical Drugs Going Off Patent
- Exhibit 7.2 The Cost to Build (CTB) a Biopharmaceutical Manufacturing Facility per
- Kiloliter (KL) of Cumulative Bioreactor Volume (CBV) as a Function of the Cumulative Volume
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