Medicines from Animal Cell Culture

The manufacture of medicines is an area of increasingly complex science and technology.  As more diverse products are developed for the treatment of human disease, many of these cannot be made by chemical synthesis.  Thus, cells of both prokaryotic and eukaryotic origin have been recruited to manufacturing processes to provide the biochemical machinery for the synthesis of natural and structurally complex molecules. This book focuses on animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin.  It also addresses the recent dramatic expansion in cell–based therapies, including the use of live cells for tissue regeneration. Stem cells in particular hold significant promise for future therapies and a chapter is dedicated to this topic.
 The book comprehensively describes the fundamentals of cell nutrition, culture, preservation and characterisation, as well as the technology and issues surrounding the production and characterisation of cell–based products. It also deals with new applications of human cells as vaccines and therapies.  The regulatory framework surrounding these new applications and biological medicines in general is addressed with reference to the developing situation around the world. Standardisation and validation are key issues in all aspects of drug development: the book addresses these and includes chapters on both GLP and GMP for cell culture processes.
 This book is written for a wide audience to provide insight into the exciting world of biological medicines and directions for further investigation into specific topics. It will be of value to researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries.

Spis treści:
Contributors.
Preface.
List of Abbreviations.
1 The Developmen t 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 Immunogenici ty 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 Canfi eld, 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.

Nota biograficzna:
Glyn Stacey works at the UK National Institute for Biological Standards and Control and is the Director of the National Stem Cell Bank. 
John Davis edited a successul book on basic cell culture.

Okładka tylna:
The manufacture of medicines is an area of increasingly complex science and technology.  As more diverse products are developed for the treatment of human disease, many of these cannot be made by chemical synthesis.  Thus, cells of both prokaryotic and eukaryotic origin have been recruited to manufacturing processes to provide the biochemical machinery for the synthesis of natural and structurally complex molecules. This book focuses on animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically e ngineered products such as tPA and erythropoietin.  It also addresses the recent dramatic expansion in cell–based therapies, including the use of live cells for tissue regeneration. Stem cells in particular hold significant promise for future therapies and a chapter is dedicated to this topic.
 The book comprehensively describes the fundamentals of cell nutrition, culture, preservation and characterisation, as well as the technology and issues surrounding the production and characterisation of cell–based products. It also deals with new applications of human cells as vaccines and therapies.  The regulatory framework surrounding these new applications and biological medicines in general is addressed with reference to the developing situation around the world. Standardisation and validation are key issues in all aspects of drug development: the book addresses these and includes chapters on both GLP and GMP for cell culture processes.
 This book is written for a wide audience to provide insight into the exciting world of biological medicines and directions for further investigation into specific topics. It will be of value to researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries.