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Medicines from animal cell culture /

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Bibliographic Details
Other Authors:	Stacey, G. (Glyn), Davis, John, 1952-
Format:	Book
Language:	English
Published:	Chichester ; Hoboken, N.J. : John Wiley & Sons, [2007]
Subjects:	Animal cell biotechnology. Pharmaceutical biotechnology. Stem cells > Transplantation. Recombinant proteins > Therapeutic use. Cell Culture Techniques > methods. Biotechnology > methods. Drug Compounding > methods.

Table of Contents:

The development of animal cell products
Water quality
Basal media and serum-free culture
Serum
Recombinant products from mammalian cells
Recombinant viral vaccines
Baculovirus expression systems
Cell cloning and stability
Gene therapy products
Culture vessels and matrices for scale-up
Process design and development
Facilities
Strategies for process contro
Service and equipment for upstream processing
Validation of facilities & equipmen
Cell harvesting and clarification of culture supernatant
Protein concentration
Chromatographic purification
Virus clearance/inactivation
Formulation and freeze-drying
Preservation of cells and tissue
From gene to product : an overview
Protein analysis
Glycosylation of medicinal products
Immunogenicity of cell derived vaccines
Potency testing
Stability of product on storage
Tissue engineering
Stem cell therapy
Cells as vaccines
Risk assessment of cells and processes
Standardisation of cell cultures
GLP for cell culture processes
GMP for cell culture processes
International regulatory framework
Legal and ethical issues for cell therapy