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

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

Large-Scale Mammalian Cell Culture is composed of papers presented as part of a symposium sponsored by the American Chemical Society Division of Microbial and Biochemical Technology at the 188th American Chemical Society National Meeting, held at Philadelphia, Pa., on Aug. 27, 1984. A rapid development of large-scale mammalian cell culture technology for the production of biologically important molecules becomes apparent. This book looks into this technology, its potential for commercial application, and the regulatory concerns posed by its use for the production of human therapeutics.

The Book This book provides the most detailed and comprehensive survey available of the different methods for production of biotechnology products from large scale mammalian and plant cell culture. Methods ranging from fermentation and encapsulation to hollow fibers and fluidized beds are described by the leaders in the field with a section on regulatory considerations. Each production method is described in detail in terms of principles, equipment and results so that informed comparisons and evaluations can be made. Contents Antibody Production with Airlift Fermentors * Monoclonal Antibody Production in Stirred Reactors * Microcarrier Cell Culture * Cellular Microencapsulation for Large-Scale Production of Monoclonal Antibodies * Entrapment of Cultured Cells in Agarose Beads * An Automated Hollow Fiber System for the Large Scale Manufacture of Mammalian Cell Secreted Product * Continuous Cell Culture with Fluidized Sponge Beads * Perfusion Cell Culture System Based on Ceramic Matrices * Large Scale Plant Cell Culture * Safety Considerations for Cell Culture-Derived Biologicals

Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

The Book This book provides the most detailed and comprehensive survey available of the different methods for production of biotechnology products from large scale mammalian and plant cell culture. Methods ranging from fermentation and encapsulation to hollow fibers and fluidized beds are described by the leaders in the field with a section on regulatory considerations. Each production method is described in detail in terms of principles, equipment and results so that informed comparisons and evaluations can be made. Contents Antibody Production with Airlift Fermentors ò Monoclonal Antibody Production in Stirred Reactors ò Microcarrier Cell Culture ò Cellular Microencapsulation for Large-Scale Production of Monoclonal Antibodies ò Entrapment of Cultured Cells in Agarose Beads ò An Automated Hollow Fiber System for the Large Scale Manufacture of Mammalian Cell Secreted Product ò Continuous Cell Culture with Fluidized Sponge Beads ò Perfusion Cell Culture System Based on Ceramic Matrices ò Large Scale Plant Cell Culture ò Safety Considerations for Cell Culture-Derived Biologicals

Production of Biologicals from Animal Cells in Culture reviews the state of the art in animal cell biotechnology, with emphasis on the sequence of events that occur when generating a biological from animal cells in culture. Methods that enable adjustment of nutrient feed streams into perfusion bioreactors so as to increase productivity are described. A number of issues are also addressed, such as the usefulness of the fingerprint method for cell characterization. Comprised of 135 chapters, this book begins with an overview of the problems and benefits of animal cell culture, followed by a discussion on the isolation of immortal murine macrophage cell lines. The reader is systematically introduced to the use of DNA fingerprinting to characterize cell banks; immortalization of cells with oncogenes; lipid metabolism of animal cells in culture; and energetics of glutaminolysis. Subsequent chapters explore serum-free and protein-free media; the physiology of animal cells; gene expression in animal cell systems; and animal cell bioreactors. The monitoring and assay of animal cell parameters are also considered, along with downstream processing and regulatory issues. This monograph will be of interest to students, practitioners, and investigators in the fields of microbiology and biotechnology.

Animal cell culture is an important laboratory technique in the biological and medical sciences. It has become an essential tool for the study of most biochemical and physiological processes and the use of large-scale animal cell culture has become increasingly important to the commercial production of specific compounds for the pharmaceutical industry. This book describes the basic requirements for establishing and maintaining cell cultures both in the laboratory and in large-scale operations. Minimal background knowledge of the subject is assumed and therefore it will be a readable introduction to animal cell culture for undergraduates, graduates and experienced researchers. Reflecting the latest developments and trends in the field, the new topics include the latest theory of the biological clock of cell lines, the development of improved serum-free media formulations, the increased understanding of the importance and control of protein glycosylation, and the humanization of antibodies for therapeutic use.

The editors have enlisted a broad range of experts, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers, who offer practical experience not found in texts and journals. This comprehensive perspective makes MIMB a valuable "how to" resource, the structure of which resembles the sequence of operation involved in the development of a commercial biological process and product.