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 

María 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