This Handbook of Pharmaceutical Biotechnology represents a unique attempt to overview the full range of approaches to discovering, selecting, and producing potentially new therapeutic moieties resulting from biological process. Such moieties are the backbone of both the pharmaceutical industry and the prime axis for the advancement of medical science.
The volume is unique in that it seeks to cover possible approaches to the biotechnology drug process as broadly as possible while not just doing so in a superficial manner. Thanks to the persistent efforts of Gladys Mok, these 50 chapters cover all major approaches to the problem of identifying, producing, and formulating new biologically derived therapeutics and were written by leading practitioners in each of these areas.
I hope that this second course of our banquet is satisfying and useful to all those working in or entering the field.
CONTENTS
1.1 From Gene to Product: The Advantage of Integrative Biotechnology
Frank-Ranier Schmidt
1.2 Sequencing the Human Genome: Was It Worth It?
Eugene Zabarovsky
1.3 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules
Günther Blaich, Bernd Janssen, Gregory Roth, and Jochen Salfeld
1.4 Integrated Development of Glycobiologics: From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems
Christine Vauthier, Isabelle Bertholon, and Denis Labarre
1.5 R&D Paradigm Shift and Billion-Dollar Biologics
Krishan Maggon
2 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care
Ioannis S. Vizirianakis
3.1 Toxicogenomics
Mary Jane Cunningham and Mrinal Shah
3.2 Preclinical Pharmacokinetics
Donald E. Mager and Murali Ramanthan
3.3 Strategies for the Cytosolic Delivery of Macromolecules: An Overview
Aravind Asokan, Roland Cheung, and Moo J. Cho
4.1 Basic Issues in the Manufacture of Macromoleucles
Corinne Lengsfeld and Thomas Anchordoquy
4.2 Process Validation for Biopharmaceuticals
Beth Junker
4.3 Stability Assessment and Formulation Characterization
Albert H.L. Chow, Henry H.Y. Tong, and Ying Zheng
4.4 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development
M.D. Mostaqul Huq and Li-Na Wei
4.5 PEGylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body’s Defense Mechanism
Yong Woo Cho, Jae Hyung Park, Ji Sun Park, and Kinam Park
4.6 Unexpected Benefits of a Formulation: Case Study with Erythropoetin
David Keast
5.1 Capillary Separation Techniques
Dong Hee Na and Kang Choon Lee
5.2 Pharmaceutical Bioassay
Jun Li, Ming Zhao, and Shiqi Peng
5.3 Analytical Considerations for Immunoassays for Macromolecules
Marian Kelley and Binodh DeSilva
5.4 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids
Jan Moebius, Remco Swart, and Albert Sickman
5.5 Bioanalytical Method Validation for Macromolecules
Gerhard K.E. Scriba
5.6 Microarrays in Drug Discovery and Development
Krishnanand D. Kumble and Sarita Kumble
5.7 Genetic Markers and Genotyping Analyses for Genetic Disease Studies
Anne E. Kwitek and Michael Olivier
6.1 Proteins: Hormones, Enzymes, and Monoclonal\Antibodies Background
Wayne Materi, Zoltan Gombos, and David S. Wishart
6.2 Formulation and Delivery Issues of Therapeutic Proteins
Sathy V. Balu-Iyer, Razvan D. Miclea, and Vivek S. Purohit
6.3 Pharmacokinetics
Nobuhito Shibata, Yukato Ito, and Kanji Takada
6.4 Immunogenicity of Therapeutic Proteins
Suzanne Hermeling, Daan J.A. Crommelin, Huub Schellekens, and Wim Jiskoot
6.5 Development and Characterization of High-Affi nity Anti-Topotecan IgG and Fab Fragments
Jin Chen and Joseph P. Balthasar
6.6 Recombinant Antibodies for Pathogen Detection and Immunotherapy
Nicholas J. Pokorny, Jeanine I. Boulter-Bitzer, J. Chris Hall, Jack T. Trevors, and Hung Lee
6.7 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies
Raymond M. Reilly
7.1 Gene Therapy—Basic Principles and the Road from Bench to Bedside
Gabor M. Rubanyi
7.2 Plasmid DNA and Messenger RNA for Therapy
Steve Pascolo
7.3 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies
Tatiana Segura
7.4 Pharmacokinetics of Nucleic-Acid-Based Therapeutics
John C. Schmitz, Aleksandra Pandyra, James Koropatnick, and Randal. W. Berg
Mandeep K. Mann and Brian E. Cairns
7.5 Case Studies—Development of Oligonucleotides
Ezharul Hoque Chowdhury and Toshihiro Akaike
7.6 RNA Interference: The Next Gene-Targeted Medicine
Andrew V. Oleinikov and Matthew D. Gray
7.7 Delivery Systems for Peptides/Oligonucleotides and Lipophilic Nucleoside Analogs
R.A. Schwendener and Herbert Schott
8.1 Growth Factors and Cytokines
Mandeep K. Mann and Brian E. Cairns
8.2 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics
Heping Cao and Rui Lin
9 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin
Vincenzo De Filippis
10.1 Production and Purification of Adenovirus Vectors for Gene Therapy
D.M.F. Prazeres and J.A.L. Santos
10.2 Assessing Gene Therapy by Molecular Imaging
Pascal Delepine and Claude Férec
11 Overview of Stem and Artificial Cells
Alejandro Soto-Gutierrez, Nalu Navarro-Alvarez, Jorge David Rivas-Carrillo, and Naoya Kobayashi
12.1 Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products
MarÃa de los Angeles Cortés Castillo and José Luis Di Fabio
12.2 Intellectual Property and Biotechnology
Tania Bubela and Karen Lynne Durell
12.3 Comparability Studies for Later-Generation Products Plant-Made Pharmaceuticals
Patrick A. Stewart
12.4 Biosimilars
H. Schellekens, W. Jiskoot, and D.J.A. Crommelin
13.1 The Promise of Individualized Therapy
Michael Oettel
13.2 Enhanced Proteomic Analysis by HPLC Prefractionation
Pierre C. Havugimana, Peter Wong, and Andrew Emili
13.3 An Overview of Metabonomics Techniques and Applications
John C. Lindon
13.4 Bioterrorism
Dany Shoham
Index
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