Table of Contents
Contributors.
Preface.
List of Abbreviations.
1 The Development of Animal Cell Products: History and Overview (B Griffiths).
FUNDAMENTAL ELEMENTS OF CELL GROWTH MEDIA.
2 Water Purity and Regulations (P Whitehead).
3 Development and Optimization of Serum-free and Protein-free Media (D Jayme).
4 Understanding Animal Sera: Considerations for Use in the Production of Biological Therapeutics (R Festen).
CELL ENGINEERING FOR RECOMBINANT PRODUCTS.
5 Expression of Recombinant Biomedical Products from Continuous Mammalian Cell Lines (SA Jeffs).
6 Production of Recombinant Viral Vaccine Antigens (SA Jeffs).
7 A Brief Overview of the Baculovirus Expression System in Insect and Mammalian Cells (C Mannix).
8 Stability: Establishing Clones, Genetic Monitoring and Biological Performance (L Barnes).
9 Gene Transfer Vectors for Clinical Applications (A Meager).
TECHNOLOGY AND FACILITIES FOR CELL CULTURE SCALE-UP.
10 Systems for Cell Culture Scale-up (J Davis).
11 Process Development and Design (DK Robinson and L Chu).
12 Facility Design for Cell Culture Biopharmaceuticals (S Vranch).
13 Monitoring, Control and Automation in Upstream Processing (TS Stoll and P Grabarek).
14 Services and Associated Equipment for Upstream Processing (TS Stoll).
15 System and Process Validation (N Chesterton).
PROCESSING AND PRESERVATION OF CELLS AND PRODUCTS.
16 Cell Harvesting (P Hill and J Bender).
17 Protein Concentration (J Bender).
18 Purification Methods (M Wilson).
19 Virus Safety of Cell-derived Biological Products (PL Roberts).
20 Formulation and Freeze Drying for Lyophilized Biological Medicines (P Matejtschuk and P Phillips).
21 Cell Preservation (R Fleck and B Fuller).
PROPERTIES OF CELL PRODUCTS.
22 Product Characterization from Gene to Therapeutic Product (K Baker, S Flatman and J Birch).
23 Protein Analysis (K Baker and S Flatman).
24 Glycosylation of Medicinal Products (E Tarelli).
25 Immunogenicity of Impurities in Cell-Derived Vaccines (M Duchene, J Descamps and I Pierard).
26 Potency and Safety Assessment of Vaccines and Antitoxins: Use of Cell-based Assays (D Sesardic).
27 Product Stability and Accelerated Degradation Studies (P Matejtschuk and P Phillips).
CELLS AS PRODUCTS.
28 Cell Culture in Tissue Engineering (TE Hardingham, CM Kielty, AE Canfield, SR Tew, SG Ball, NJ Turner and KE Ratcliffe).
29 The Use of Stem Cells in Cell Therapy (F Martín, J Jones, P Vaca, G Berná and B Soria).
30 Cells as Vaccines (AG Dalgleish and MA Whelan).
RISK ASSESSMENT AND REGULATORY ASPECTS.
31 Risk Assessment of Cell Culture Procedures (G Stacey).
32 Standardization of Cell Culture Procedures (G Stacey).
33 Good Laboratory Practice for Cell Culture Processing (B Orton).
34 Good Manufacturing Practice for Cell Culture Processing (A Green and G Sharpe).
35 International Regulatory Framework (R Guenther).
36 New Areas: Cell Therapy and Tissue Engineering Products – Technical, Legal and Regulatory Considerations (L Tsang).
Index.
