HANDBOOK OF PHARMACEUTICAL BIOTECHNOLOGY -- CONTRIBUTORS -- CONTENTS -- Preface -- 1.1 From Gene to Product: The Advantage of Integrative Biotechnology -- 1.2 Sequencing the Human Genome: Was It Worth It? -- 1.3 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules -- 1.4 Integrated Development of Glycobiologics: From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems -- 1.5 R&D Paradigm Shift and Billion-Dollar Biologics -- 2 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care -- 3.1 Toxicogenomics -- 3.2 Preclinical Pharmacokinetics -- 3.3 Strategies for the Cytosolic Delivery of Macromolecules: An Overview -- 4.1 Basic Issues in the Manufacture of Macromoleucles -- 4.2 Process Validation for Biopharmaceuticals -- 4.3 Stability Assessment and Formulation Characterization -- 4.4 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development -- 4.5 PEGylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism -- 4.6 Unexpected Benefits of a Formulation: Case Study with Erythropoetin -- 5.1 Capillary Separation Techniques -- 5.2 Pharmaceutical Bioassay -- 5.3 Analytical Considerations for Immunoassays for Macromolecules -- 5.4 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids -- 5.5 Bioanalytical Method Validation for Macromolecules -- 5.6 Microarrays in Drug Discovery and Development -- 5.7 Genetic Markers and Genotyping Analyses for Genetic Disease Studies -- 6.1 Proteins: Hormones, Enzymes, and Monoclonal\Antibodies-Background -- 6.2 Formulation and Delivery Issues of Therapeutic Proteins -- 6.3 Pharmacokinetics -- 6.4 Immunogenicity of Therapeutic Proteins.

6.5 Development and Characterization of High-Affinity Anti-Topotecan IgG and Fab Fragments -- 6.6 Recombinant Antibodies for Pathogen Detection and Immunotherapy -- 6.7 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies -- 7.1 Gene Therapy-Basic Principles and the Road from Bench to Bedside -- 7.2 Plasmid DNA and Messenger RNA for Therapy -- 7.3 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies -- 7.4 Pharmacokinetics of Nucleic-Acid-Based Therapeutics -- 7.5 Case Studies-Development of Oligonucleotides -- 7.6 RNA Interference: The Next Gene-Targeted Medicine -- 7.7 Delivery Systems for Peptides/Oligonucleotides and Lipophilic Nucleoside Analogs -- 8.1 Growth Factors and Cytokines -- 8.2 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics -- 9 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin -- 10.1 Production and Purification of Adenovirus Vectors for Gene Therapy -- 10.2 Assessing Gene Therapy by Molecular Imaging -- 11 Overview of Stem and Artificial Cells -- 12.1 Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products -- 12.2 Intellectual Property and Biotechnology -- 12.3 Comparability Studies for Later-Generation Products-Plant-Made Pharmaceuticals -- 12.4 Biosimilars -- 13.1 The Promise of Individualized Therapy -- 13.2 Enhanced Proteomic Analysis by HPLC Prefractionation -- 13.3 An Overview of Metabonomics Techniques and Applications -- 13.4 Bioterrorism -- Index.