An interdisciplinary approach, integrating biochemistry, biology, genetics, and engineering for the effective production of protein pharmaceuticals. The volume offers a biological perspective of large-scale animal cell culture and examines diverse processing strategies, process management, regulator
Series Introduction
Preface
Contributors
Large-Scale Mammalian Cell Culture: A Perspective
N. B. Finter, A. J. M. Garland, and R. C. Telling
Use of Recombinant DNA Technology for Engineering Mammalian Cells to Produce Proteins
Randal J. Kaufman
Large-Scale Animal Cell Culture: A Biological Perspective
Melvin S. Oka and Randall G. Rupp
Mammalian Cell Physiology
James N. Thomas
Cell Banking
Michael E. Wiebe and Laurie H. May
Expression of Cloned Proteins in Mammalian Cells: Regulation of Cell-Associated Parameters
Jennie P. Mather and Mary Tsao
Assay Requirements for Cell Culture Process Development
Mary B. Sliwkowski and Edward T. Cox
Noperfused Attachment System for Cell Cultivation
Arthur Y. Elliot
Perfusion Systems for Cell Cultivation
Bryan Griffiths
Suspension Culture of Mammalian Cells
John R. Birch and Robert Arathoon
Microcarrier Culture Systems
Shaul Reuveny
Microencapsulation of Mammalian Cells
Joseph E. Tyler
Continuous Culture with Macroporous Matrix, Fluidized Bed Systems
Peter W. Runstadler, Jr., Amar S. Tung, Edward G. Hayman, NItya G. Ray, Johanna V. G. Sample, and David E. DeLucia
Downstream Processing of Proteins from Mammalian Cells
John R. Ogez and Stuart E. Builder
Management of Process Technology
Donald G. Bergmann
Monitoring and Control of Animal Cell Bioreactors Biochemical Engineering Considerations
Wei-Shou Hu and Mark G. Oberg
Methods for the Detection of Adventitious Viruses in Cell Cultures Used in the Production of Biotechnology Products
Judith A. Poiley
Continuous Cell Substrate Considerations
Anthony S. Lubiniecki
Process Validation for Cell Culture-Derived Pharmaceurical Proteins
Anthony S. Lubiniecki, Michael E. Wiebe, and Stuart E. Builder
Quality Control of rDNA-Derived Human Tissue-Type Plasminogen Activator
Andrew J. S. Jones and Robert L. Garnick
Design and Construction of Manufacturing Facilities for Mammalian Cell-Derived Pharmaceuticals
William R. Srigley
Large-Scale Propagation of Insect Cells
James L. Vaughn and Stefan A. Weiss
Index
Biography
Anthony S. Lubiniecki
