Regulatory Framework for Biosimilars
The term “biopharmaceuticals” is used to describe biotechnologically derived drug products. Biopharmaceuticals are protein-based macromolecules and include insulin, human growth hormone, the families of the cytokines and of the monoclonal antibodies/antib
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Pharmaceutical Biotechnology Fundamentals and Applications Fourth Edition
Pharmaceutical Biotechnology
Daan J.A. Crommelin • Robert D. Sindelar Bernd Meibohm Editors
Pharmaceutical Biotechnology Fundamentals and Applications Fourth Edition
Editors Daan J.A. Crommelin, Ph.D. Department of Pharmaceutical Sciences Utrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands
Robert D. Sindelar, Ph.D., FCAHS Department of Pharmaceutical Sciences and Department of Medicine Providence Health Care and The University of British Columbia Vancouver, BC Canada
Bernd Meibohm, Ph.D., FCP Department of Pharmaceutical Sciences University of Tennessee Health Science Center College of Pharmacy Memphis, Tennessee USA
ISBN 978-1-4614-6485-3 ISBN 978-1-4614-6486-0 DOI 10.1007/978-1-4614-6486-0 Springer New York Heidelberg Dordrecht London
(eBook)
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Contents Preface vii Abbreviations ix Contributors xix 1. Molecular Biotechnology: From DNA Sequence to Therapeutic Protein 1 Ronald S. Oosting 2. Biophysical and Biochemical Analysis of Recombinant Proteins 19 Tsutomu Arakawa and John S. Philo 3. Production and
