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|publication info||S. Gad, ed., John Wiley & Sons, 2007, 1680 pp., hard cover|
This Handbook 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, and features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics
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 Defi ning 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 Modifi cation: A Potential Target in Pharmaceutical Development
4.5 PEGylation: Camoufl age of Proteins, Cells, and Nanoparticles Against Recognition by the Body’s Defense Mechanism
4.6 Unexpected Benefi ts 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—Bac
6.2 Formulation and Delivery Issues of Therapeutic Proteins
6.4 Immunogenicity of Therapeutic Proteins
6.5 Development and Characterization of High-Affi nity 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
8.2 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics .
9 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin .
10.1 Production and Purifi cation of Adenovirus Vectors for Gene Therapy
10.2 Assessing Gene Therapy by Molecular Imaging
11 Overview of Stem and Artifi cial 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 (Dany Shoham).
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recombinant, expressed in Saccharomyces cerevisiae, ≥7,000 ATU/mg protein (ATU = antithrombin units)
Stabilize and protect RNA with immediate RNase inactivation
≥98% (HPLC and enzymatic)
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