3773

[edited by] Glyn Stacey, John Davis

Wiley

c2007

xvi, 672 p. ill.

Includes bibliographical references and index , The development of animal cell products / J.B. Griffiths -- Water quality / P. Whitehead -- Basal media and serum-free culture / David Jayme -- Serum / Richard Festen -- Recombinant products from mammalian cells / S. Jeffs -- Recombinant viral vaccines / S. jeffs -- Baculovirus expression systems / C. Mannix -- Cell cloning and stability / L. Barnes -- Gene therapy products / A. Meager -- Culture vessels and matrices for scale-up / J.M. Davis -- Process design and development / D. Robinson & E. Chu -- Facilities / S. Vranche -- Strategies for process control / T. Stoll -- Service and equipment for upstream processing / T. Stoll -- Validation of facilities & equipment / N. Chesterton and J. Davis -- Cell harvesting and clarification of culture supernatants / J. Bender -- Protein concentration / Jean Bender -- Chromatographic purification / M. Wilson -- Virus clearance/inactivation / P. Roberts -- Formulation and freeze-drying / P. Matejschuk and P. Phillips -- Preservation of cells and tissue / R. Fleck & B. Fuller -- From gene to product : an overview / J. Birch and K. Baker -- Protein analysis / K. Baker and S. Flatman -- Glycosylation of medicinal products / E. Tarelli -- Immunogenicity of cell derived vaccines / Michele Duchene -- Potency testing / D. Sesardic -- Stability of product on storage / P. Matejtscuk and P. Phillips -- Tissue engineering / T. Hardingham et al -- Stem cell therapy / Bernat Soria et al -- Cells as vaccines / Dalgleish and Whelan -- Risk assessment of cells and processes / G. Stacey -- Standardisation of cell cultures / G. Stacey -- GLP for cell culture processes / B. Orton -- GMP for cell culture processes / G. Sharp -- International regulatory framework / R. Gunther -- Legal and ethical issues for cell therapy / Lincoln Tsang.

Stacey, G. , Davis, John,

615

.19

M4687