a practical guide to manufacturing, preclinical and clinical development /
First Statement of Responsibility
edited by K. John Morrow Jr., Cheng Liu
PROJECTED PUBLICATION DATE
Date
1611
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
1 online resource
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index
CONTENTS NOTE
Text of Note
The history of therapeutic monoclonal antibodies / Regis Sodoyer -- Structure, classification and naming of therapeutic monoclonal antibodies / Zhinan Xia -- Mechanism of action for therapeutic antibodies / Yu Zhou and James D. Marks -- Therapeutic monoclonal antibodies and their targets / Maurizio Chiriva-Internati, et al -- Antibody post-translational modifications / Roy Jefferis -- The pharmacology, pharmacokinetics, and pharmacodynamics of antibodies / Ningning Xu, Meimei Liu, Margaret Liu -- Monoclonal antibodies : applications in clinical oncology / Jeanene ("Gigi") Robison -- Development of biosimilar rituximab and clinical experience / Reena Nair -- Monoclonal antibodies for infectious diseases / Steven J. Projan -- Monoclonal antibodies for musculoskeletal, CNS, and other diseases / Junming Yie and Tao Wu -- Manufacture of recombinant therapeutic proteins using chinese hamster ovary cells in large-scale bioreactors : history, methods and perspectives / Florian M. Wurm and Maria De Jesus -- Process development / Samuel D. Stimple and David W. Wood -- Biosimilars and biobetters : impact on biopharmaceutical manufacturing and CMOs / Ronald A. Rader -- Cell line and cell culture development for biosimilar antibody drug manufacturing / Jianguo Yang -- Product analysis of biosimilar antibodies / Weidong Jiang, Scott Liu and Ziyang Zhong -- Bioanalytical development / Rafiq Islam -- Preclinical and clinical development of biosimilar antibodies / João Eurico Fonseca and João Gonçalves -- Regulatory issues / Clarinda Islam -- Legal considerations / K. Lance Anderson, Jennifer R. Moore Meline, and Jonathan D. Ball -- ADCC enhancement technologies for next generation therapeutic antibodies / Cheng Liu and Su Yan -- Biosimilar antibody half-life : engineering for optimal performance / K. John Morrow, Jr -- Technologies for antibody drug conjugation / Patrick G. Holder and David Rabuka