Main description:

A practical overview of a full rangeof approaches todiscovering, selecting, and producing biotechnology–deriveddrugs

The Handbook of Pharmaceutical Biotechnology helpspharmaceutical scientists develop biotech drugs through acomprehensive framework that spans the process from discovery,development, and manufacturing through validation and registration.With chapters written by leading practitioners in their specialtyareas, this reference:

• Provides an overview of biotechnology used in the drugdevelopment process




• Covers extensive applications, plus regulations and validationmethods




• Features fifty chapters covering all the major approaches to thechallenge of identifying, producing, and formulating newbiologically derived therapeutics

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

Back cover:

A practical overview of a full rangeof approaches todiscovering, selecting, and producing biotechnology–deriveddrugs

The Handbook of Pharmaceutical Biotechnology helpspharmaceutical scientists develop biotech drugs through acomprehensive framework that spans the process from discovery,development, and manufacturing through validation and registration.With chapters written by leading practitioners in their specialtyareas, this reference:

• Provides an overview of biotechnology used in the drugdevelopment process




• Covers extensive applications, plus regulations and validationmethods




• Features fifty chapters covering all the major approaches to thechallenge of identifying, producing, and formulating newbiologically derived therapeutics

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

Contents:

Preface.

1.1 From Gene to Product: The Advantage of IntegrativeBiotechnology (Frank–Ranier Schmidt).

1.2 Sequencing the Human Genome: Was It Worth It? (EugeneZabarovsky).

1.3 Overview: Differentiating Issues in the Development ofMacromolecules Compared with Small Molecules (GüntherBlaich, Bernd Janssen, Gregory Roth, and Jochen Salfeld).

1.4 Integrated Development of Glycobiologics: From Discovery toApplications in the Design of Nanoparticular Drug Delivery Systems(Christine Vauthier, Isabelle Bertholon, and DenisLabarre).

1.5 R&D Paradigm Shift and Billion–Dollar Biologics(Krishan Maggon).

2 From Defi ning Bioinformatics and Pharmacogenomics toDeveloping Information–Based Medicine and Pharmacotyping in HealthCare (Ioannis S. Vizirianakis).

3.1 Toxicogenomics (Mary Jane Cunningham and MrinalShah).

3.2 Preclinical Pharmacokinetics (Donald E. Mager and MuraliRamanthan).

3.3 Strategies for the Cytosolic Delivery of Macromolecules: AnOverview (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 (BethJunker).

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 Targetin Pharmaceutical Development (M.D. Mostaqul Huq and Li–NaWei).

4.5 PEGylation: Camoufl age of Proteins, Cells, andNanoparticles Against Recognition by the Body s DefenseMechanism (Yong Woo Cho, Jae Hyung Park, Ji Sun Park, and KinamPark).

4.6 Unexpected Benefi ts of a Formulation: Case Study withErythropoetin (David Keast).

5.1 Capillary Separation Techniques (Dong Hee Na and KangChoon Lee).

5.2 Pharmaceutical Bioassay (Jun Li, Ming Zhao, and ShiqiPeng).

5.3 Analytical Considerations for Immunoassays forMacromolecules (Marian Kelley and Binodh DeSilva).

5.4 Chromatography–Based Separation of Proteins, Peptides, andAmino Acids (Jan Moebius, Remco Swart, and AlbertSickman).

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 DiseaseStudies (Anne E. Kwitek and Michael Olivier).

6.1 Proteins: Hormones, Enzymes, andMonoclonal\Antibodies Background (Wayne Materi, ZoltanGombos, 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 KanjiTakada).

6.4 Immunogenicity of Therapeutic Proteins (SuzanneHermeling, Daan J.A. Crommelin, Huub Schellekens, and WimJiskoot).

6.5 Development and Characterization of High–Affi nityAnti–Topotecan IgG and Fab Fragments (Jin Chen and Joseph P.Balthasar).

6.6 Recombinant Antibodies for Pathogen Detection andImmunotherapy (Nicholas J. Pokorny, Jeanine I. Boulter–Bitzer,J. Chris Hall,Jack T. Trevors, and Hung Lee).

6.7 The Radiopharmaceutical Science of Monoclonal Antibodies andPeptides for Imaging and Targeted in situ Radiotherapy ofMalignancies (Raymond M. Reilly).

7.1 Gene Therapy Basic Principles and the Road from Benchto Bedside (Gabor M. Rubanyi).

7.2 Plasmid DNA and Messenger RNA for Therapy (StevePascolo).

7.3 Formulations and Delivery Limitations of Nucleic–Acid–BasedTherapies (Tatiana Segura).

7.4 Pharmacokinetics of Nucleic–Acid–Based Therapeutics (JohnC. 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 (AndrewV. Oleinikov and Matthew D. Gray).

7.7 Delivery Systems for Peptides/Oligonucleotides andLipophilic Nucleoside Analogs (R.A. Schwendener and HerbertSchott).

8.1 Growth Factors and Cytokines (Mandeep K. Mann and BrianE. 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 toHirudin (Vincenzo De Filippis).

10.1 Production and Purifi cation of Adenovirus Vectors for GeneTherapy (D.M.F. Prazeres and J.A.L. Santos).

10.2 Assessing Gene Therapy by Molecular Imaging (PascalDelepine and Claude Férec).

11 Overview of Stem and Artifi cial Cells (AlejandroSoto–Gutierrez, Nalu Navarro–Alvarez, Jorge David Rivas–Carrillo,and Naoya Kobayashi).

12.1 Regulation of Small–Molecule Drugs Versus BiologicalsVersus Biotech Products (María de los Angeles CortésCastillo and José Luis Di Fabio).

12.2 Intellectual Property and Biotechnology (Tania Bubelaand Karen Lynne Durell).

12.3 Comparability Studies for Later–GenerationProducts 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 (MichaelOettel).

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.