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Handbook of Pharmaceutical Biotechnology

Shayne Cox Gad (Editor)
ISBN: 978-0-470-11710-1
1680 pages
May 2007
Handbook of Pharmaceutical Biotechnology (0470117109) cover image


A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs

The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference:

  • Provides an overview of biotechnology used in the drug development process
  • Covers extensive applications, plus regulations and validation methods
  • Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics

With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

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Table of 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 Defi ning 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 Modifi cation: A Potential Target in Pharmaceutical Development (M.D. Mostaqul Huq and Li-Na Wei).

4.5 PEGylation: Camoufl age 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 Benefi ts 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).

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 Purifi cation 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 Artifi cial 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).


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Author Information

Shayne Cox GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. He has more than thirty years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books, including Drug Discovery Handbook (Wiley), and numerous papers, presentations, and other publications.
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"In summary, the Handbook of Pharmaceutical Biotechnoloyg is an invaluable addition to the bookshelf of any biopharmaceutical scientist. It is not only useful as a reference book, but also enjoyable to read as a textbook due to the topical and well-written subject matter. . . highly recommended." (Biochemist, 1 April 2011)

"I think this is an excellent book certainly the best of its kind I have come across." (BTS Newsletter, Summer 2008)

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