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Title Current trends in monoclonal antibody development and manufacturing / edited by Steven J. Shire [and others].
Imprint New York : Springer : AAPS Press, 2010.

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Series Biotechnology: pharmaceutical aspects ; v. 11
Biotechnology (Arlington, Va.) ; v. 11.
Subject Monoclonal antibodies.
Antibodies, Monoclonal -- biosynthesis.
Antibodies, Monoclonal -- analysis.
Antibodies, Monoclonal -- pharmacokinetics.
Biotechnology -- methods.
Alt Name Shire, Steven J.
American Association of Pharmaceutical Scientists.
Description 1 online resource (xiv, 351 pages) : illustrations (some color).
polychrome rdacc
Bibliography Note Includes bibliographical references and index.
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 [and others] -- 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 [and others] -- 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 [and others] -- 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.
Summary Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
Note Print version record.
ISBN 9780387766430 (e-isbn)
038776643X (e-isbn)
9780387766423
0387766421
OCLC # 663093815
Additional Format Print version: Current trends in monoclonal antibody development and manufacturing. New York : Springer : AAPS Press, 2010 9780387766423 (DLC) 2009938432 (OCoLC)496951432


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