Bookedited by Steven J. Shire, Genentech, Inc., San Francisco, CA USA, Wayne Gombotz, Omeros Corporation, Seattle, WA USA, Karoline Bechtold-Peters, Boehringer Ingelheim Pharma, Biberach, Germany, James Andya, Genentech, Inc., San Francisco, CA USA.
Contents:
Introduction / Wayne R. Gombotz and Steven J. Shire
Design of therapeutic MABS. CDR repair: a novel approach to antibody humanization / Mark S. Dennis
Nanobodies, single-domain antigen-binding fragments of camelid heavy-chain antibodies / Gholamreza Hassanzadeh Ghassabeh, Serge Muyldermans, and Dirk Saerens
Expression and production of MABS. GPEx® a flexible method for the rapid generation of stable, high expressing, antibody producing mammalian cells lines / Gregory T. Bleck
Advancing our cell culture platform: incorporating lessons learned and new technologies / Carole Heath
Recovery and purification. Addressing changes associated with technology transfer: a case study / Michele M. Myers ... [et al.]
Concepts for disposables in biopharmaceutical manufacture / Joachim K. Walter and Uwe Gottschalk
Formulation and delivery. Formulation and delivery issues for monoclonal antibody therapeutics / Ann L. Daugherty and Randall J. Mrsny
Challenges in the development of high protein concentration formulations / Steven J. Shire, Zahra Shahrock, and Jun Liu
Protein immobilization by crystallization and precipitation: an alternative to lyophilization / Karoline Bechtold-Peters
Analytics and specification setting for MABS. Characterizing high affinity antigen/antibody complexes by kinetic and equilibrium based methods / Andrew W. Drake, David G. Myszka, and Scott L. Klakamp
Analytical characterization of monoclonal antibodies: linking structure to function / Reed J. Harris ... [et al.]
Analysis of irreversible aggregation, reversible self-association and fragmentation of monoclonal antibodies by analytical ultracentrifugation / James D. Andya, Jun Liu, and Steven J. Shires
Biophysical signatures of monoconal antibodies / N. Harn ... [et al.]
Pharmacokinetics and immunogenicity. Impact of Fc glycosylation on monoclonal antibody effector functions and degradation by proteases / T. Shantha Raju
Immunogenicity assessment of antibody therapeutics / P. stas, Y. Gansemans, and I. Lasters
Armed antibodies and new classes of antibodies. Production of monoclonal antibodies in E. coli / Dorothea E. Reilly and Daniel G. Yansura
Recent advances in the use of antibody drug conjugates for cancer theapy / Peter D. Senter
Antibody radiolabeling / Corinne Bensimon and Russell Redshaw.