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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