Therapeutic Fc-Fusion Proteins

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.

Steven Chamow, Ph.D.
Steven Chamow has developed biopharmaceutical products for 24 years. During his career, he has contributed to the development of three marketed products (Avastin, Natrecor, Vectibix). He served in executive roles at several companies including Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics), Genitope Corporation, and Abgenix, Inc., (acquired by Amgen) where he built the company?s process sciences department and co-lead the design and construction of Abgenix? award-winning production facility in Fremont, CA (recently sold by Amgen to Boehringer-Ingelheim to become its first North American production facility). Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc. (acquired by J&J), and as a scientist and senior scientist in process development at Genentech, Inc. (acquired by Roche). Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health. He is author or co-author of more than 45 scientific publications and patents and co-editor of a 1999 book entitled Antibody Fusion Proteins. He lives in San Mateo, CA, with his wife.

Thomas Ryll, Ph.D.
Senior Director, Bioprocess Development
Biogen Idec
14 Cambridge Center
Cambridge, MA 02142
thomas.ryll@biogenidec.com

Henry B. Lowman, Ph.D.
Chief Scientific Officer
CytomX Therapeutics, Inc.
650 Gateway Blvd.
South San Francisco, CA 94080
henry@cytomx.com

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.)