Major Handbook of Pharmaceutical Biotechnology
from C.H.I.P.S.

Handbook of Pharmaceutical Biotechnology
edited by Shayne Cox Gad

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.


  • 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


  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


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Handbook of Pharmaceutical Biotechnology
edited by Shayne Cox Gad
2007 • 1,659 pages • $194.00 + shipping
Texas residents please add 6.75 % sales tax

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