Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for
human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future.
An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.
human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future.
An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.
Table of Contents
Introduction: Antibody Structure and Function (Pons, J., Rajpal, A., Strop, P., Yeung, Y.A., Chaparro-Riggers, J.)
PART I: METHODS OF PRODUCTION FOR Fc-FUSION PROTEINS
Fc-Fusion Protein Expression Technology (Berry, J., Yang, C., Fisher, J., Mendoza, E., Young, S., Stupack, D.)
Cell Culture Based Production (Ryll, Th., Huang, Y.-M., Kshirsagar, R., Woppmann, B.)
Downstream Processing of Fc-Fusion Proteins (Shukla, A.A., Gottschalk, U.)
Formulation, Drug Product, and Delivery: Considerations for Fc-Fusion Proteins (Yeh, P.Y., Cao, W., Piedmonte, D.M., Ricci, M.S.)
Quality by Design Applied to a Fc-fusion Protein: A Case Study (Broly, H., Eon-Duval, A., Gleixner, R.;
Valax, P., Soos, M., Neunstoecklin, B., Morbidelli, M.)
Analytical Methods Used to Characterize Fc-fusion Proteins (Mulkerrin, M., Idusogie, E.)
PART II: CASE STUDIES OF THERAPEUTIC Fc-FUSION PROTEINS
Introduction to Therapeutic Fc-fusion Proteins (Berry, J.D.)
Alefacept (Farson, D.A., Grossman, J.)
Etanercept (Grossman, J., Chamow, S.M.)
Abatacept and Belatacept (Peach, R.J.)
Aflibercept (Chamow, S.M., Linderholm, A.L.)
Recombinant Factor VIII- and Factor IX-Fc-Fusions (Peters, R.)
