Medicines from Animal Cell Culture
(Sprache: Englisch)
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...
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Klappentext zu „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.
Inhaltsverzeichnis zu „Medicines from Animal Cell Culture “
Preface.Foreword.
History and Overview:
1 The Development of Animal Cell Products, JB Griffiths .
Fundamental Elements of Cell Growth Media:
2 Water Quality, P Whitehead.
3 Basal Media and Serum-free Culture, David Jayme, (JD on basal media).
4 Serum, Richard Festen , JRH.
Cell Engineering for Recombinant Products:
5 Recombinant Products from Mammalian Cells , S Jeffs, UCL .
6 Recombinant Viral Vaccines S Jeffs, UCL.
7 Baculovirus expression systems, C Mannix.
8 Cell Cloning and Stability, L Barnes, Univ. Manchester.
9 Gene Therapy Products, A Meager NIBSC.
Technology and Facilities for Cell Culture Scale-up:
10 Culture Vessels and Matrices for Scale-up, JM Davis.
11 Process Design and Development, D Robinson & E Chu.
12 Facilities , S Vranche, Jacobs Eng.
13 Strategies for Process Control , T Stoll.
14 Service and equipment for upstream processing, T Stoll.
15 Validation of Facilities & Equipment, N Chesterton and J Davis, BPL.
Processing and Preservation of Cells and Products:
16 Cell Harvesting and Clarification of Culture Supernatants, J Bender.
17 Protein Concentration, Jean Bender,.
18 Chromatographic purification , M Wilson.
19 Virus clearance/inactivation P Roberts, NPL.
20 Formulation and freeze-drying, P Matejschuk and P Phillips, NIBSC .
21 Preservation of Cells and Tissue, R Fleck (NIBSC) & B Fuller (Royal Free Hosp).
Properties of Cell Products:
22 From Gene To Product: An Overview, J Birch and K Baker, Lonza.
23 Protein analysis: K Baker and S Flatman, Lonza.
24 Glycosylation of Medicinal Products E Tarelli, KCL.
25 Immunogenicity of Cell Derived Vaccines, Michele Duchene, GSK.
26 Potency testing D Sesardic, NIBSC.
27 Stability of Product on Storage P Matejtscuk and P Phillips, NIBSC.
Cells as Products.
28 Tissue Engineering, T Hardingham et al, UMIST.
29 Stem Cell Therapy, Bernat Soria et al.
30 Cells as Vaccines Dalgleish and Whelan,
... mehr
Onyvax.
Risk Assessment and Regulatory Aspects.
31 Risk Assessment of Cells and Processes, G Stacey, NIBSC.
32 Standardisation of Cell Cultures, G Stacey, NIBSC.
33 GLP for Cell Culture Processes, B Orton, NPL.
34 GMP for Cell Culture Processes, G Sharp, Cobra Ltd.
35 International Regulatory Framework, R Gunther.
36 Legal and Ethical Issues for Cell Therapy, Lincoln Tsang.
Risk Assessment and Regulatory Aspects.
31 Risk Assessment of Cells and Processes, G Stacey, NIBSC.
32 Standardisation of Cell Cultures, G Stacey, NIBSC.
33 GLP for Cell Culture Processes, B Orton, NPL.
34 GMP for Cell Culture Processes, G Sharp, Cobra Ltd.
35 International Regulatory Framework, R Gunther.
36 Legal and Ethical Issues for Cell Therapy, Lincoln Tsang.
... weniger
Autoren-Porträt
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.
Bibliographische Angaben
- 2007, 1. Auflage, 448 Seiten, Maße: 24,4 cm, Gebunden, Englisch
- Herausgegeben: Glyn N. Stacey, John Davis
- Verlag: Wiley & Sons
- ISBN-10: 0470850949
- ISBN-13: 9780470850947
Sprache:
Englisch
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