Handbook of Pharmaceutical Biotechnology

Front Cover
Shayne Cox Gad
John Wiley & Sons, 2007 M05 25 - 1680 pages
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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Contents

11 From Gene to Product The Advantage of Integrative Biotechnology
1
12 Sequencing the Human Genome Was It Worth It?
53
13 Overview Differentiating Issues in the Development of Macromolecules Compared with Small Molecules
89
14 Integrated Development of Glycobiologics From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems
125
15 RD Paradigm Shift and BillionDollar Biologics
161
2 From Defining Bioinformatics and Pharmacogenomics to Developing InformationBased Medicine and Pharmacotyping in Health Care
201
31 Toxicogenomics
229
32 Preclinical Pharmacokinetics
253
65 Development and Characterization of HighAffinity AntiTopotecan IgG and Fab Fragments
835
66 Recombinant Antibodies for Pathogen Detection and Immunotherapy
851
67 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies
883
71 Gene TherapyBasic Principles and the Road from Bench to Bedside
943
72 Plasmid DNA and Messenger RNA for Therapy
971
73 Formulations and Delivery Limitations of NucleicAcidBased Therapies
1013
74 Pharmacokinetics of NucleicAcidBased Therapeutics
1061
75 Case StudiesDevelopment of Oligonucleotides
1087

33 Strategies for the Cytosolic Delivery of Macromolecules An Overview
279
41 Basic Issues in the Manufacture of Macromoleucles
297
42 Process Validation for Biopharmaceuticals
319
43 Stability Assessment and Formulation Characterization
371
44 Protein Posttranslational Modification A Potential Target in Pharmaceutical Development
417
45 PEGylation Camouflage of Proteins Cells and Nanoparticles Against Recognition by the Bodys Defense Mechanism
443
46 Unexpected Benefits of a Formulation Case Study with Erythropoetin
463
51 Capillary Separation Techniques
469
52 Pharmaceutical Bioassay
511
53 Analytical Considerations for Immunoassays for Macromolecules
573
54 ChromatographyBased Separation of Proteins Peptides and Amino Acids
585
55 Bioanalytical Method Validation for Macromolecules
611
56 Microarrays in Drug Discovery and Development
633
57 Genetic Markers and Genotyping Analyses for Genetic Disease Studies
661
61 Proteins Hormones Enzymes and MonoclonalAntibodiesBackground
691
62 Formulation and Delivery Issues of Therapeutic Proteins
737
63 Pharmacokinetics
757
64 Immunogenicity of Therapeutic Proteins
815
76 RNA Interference The Next GeneTargeted Medicine
1109
77 Delivery Systems for PeptidesOligonucleotides and Lipophilic Nucleoside Analogs
1149
81 Growth Factors and Cytokines
1173
82 Growth Factors Cytokines and Chemokines Formulation Delivery and Pharmacokinetics
1197
9 Protein Engineering with Noncoded Amino Acids Applications to Hirudin
1225
101 Production and Purification of Adenovirus Vectors for Gene Therapy
1261
102 Assessing Gene Therapy by Molecular Imaging
1297
11 Overview of Stem and Artificial Cells
1313
121 Regulation of SmallMolecule Drugs Versus Biologicals Versus Biotech Products
1373
122 Intellectual Property and Biotechnology
1391
123 Comparability Studies for LaterGeneration ProductsPlantMade Pharmaceuticals
1433
124 Biosimilars
1453
131 The Promise of Individualized Therapy
1463
132 Enhanced Proteomic Analysis by HPLC Prefractionation
1491
133 An Overview of Metabonomics Techniques and Applications
1503
134 Bioterrorism
1525
Index
1653
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About the author (2007)

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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