Handbook of Pharmaceutical Biotechnology contains practical coverage of a full range of approaches to discovering, selecting, and producing biotechnology-derived drugs.

The Handbook of Pharmaceutical Biotechnology will help pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration.

Features:

• 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

Contents

1. From Gene to Product: The Advantage of Integrative Biotechnology
2. Sequencing the Human Genome: Was It Worth It?
3. Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules
4. Integrated Development of Glycobiologics: From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems
5. R&D Paradigm Shift and Billion-Dollar Biologics
6. From Defi ning Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care
7. Toxicogenomics
8. Preclinical Pharmacokinetics
9. Strategies for the Cytosolic Delivery of Macromolecules: An Overview
10. Basic Issues in the Manufacture of Macromoleucles
11. Process Validation for Biopharmaceuticals
12. Stability Assessment and Formulation Characterization
13. Protein Posttranslational Modifi cation: A Potential Target in Pharmaceutical Development
14. PEGylation: Camoufl age of Proteins, Cells, and Nanoparticles Against Recognition by the Body’s Defense Mechanism
15. Unexpected Benefi ts of a Formulation: Case Study with Erythropoetin
16. Capillary Separation Techniques
17. Pharmaceutical Bioassay
18. Analytical Considerations for Immunoassays for Macromolecules
19. Chromatography-Based Separation of Proteins, Peptides, and Amino Acids
20. Bioanalytical Method Validation for Macromolecules
21. Microarrays in Drug Discovery and Development
22. Genetic Markers and Genotyping Analyses for Genetic Disease Studies
23. Proteins: Hormones, Enzymes, and Monoclonal\Antibodies—Background
24. Formulation and Delivery Issues of Therapeutic Proteins
25. Pharmacokinetics
26. Immunogenicity of Therapeutic Proteins
27. Development and Characterization of High-Affi nity Anti-Topotecan IgG and Fab Fragments
28. Recombinant Antibodies for Pathogen Detection and Immunotherapy
29. The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies
30. Gene Therapy—Basic Principles and the Road from Bench to Bedside
31. Plasmid DNA and Messenger RNA for Therapy
32. Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies
33. Pharmacokinetics of Nucleic-Acid-Based Therapeutics
34. Case Studies—Development of Oligonucleotides
35. RNA Interference: The Next Gene-Targeted Medicine
36. Delivery Systems for Peptides/Oligonucleotides and Lipophilic Nucleoside Analogs
37. Growth Factors and Cytokines
38. Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics
39. Protein Engineering with Noncoded Amino Acids: Applications to Hirudin
40. Production and Purifi cation of Adenovirus Vectors for Gene Therapy
41. Assessing Gene Therapy by Molecular Imaging
42. Overview of Stem and Artifi cial Cells
43. Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products
44. Intellectual Property and Biotechnology
45. Comparability Studies for Later-Generation Products—Plant-Made Pharmaceuticals
46. Biosimilars
47. The Promise of Individualized Therapy
48. Enhanced Proteomic Analysis by HPLC Prefractionation
49. An Overview of Metabonomics Techniques and Applications
50. Bioterrorism

Index

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