Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs / Edition 1

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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.

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Editorial Reviews

From the Publisher
“...a useful book for a...class in the pharmacology and pharmacokinetics of biotechnology-derived products, as well as a good introductory book for people new to the biotechnology industry.” (Pharmaceutical Research, Vol. 20, No. 12, December 2003)
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Product Details

  • ISBN-13: 9780471206903
  • Publisher: Wiley
  • Publication date: 8/1/2003
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 576
  • Product dimensions: 7.13 (w) x 10.14 (h) x 1.25 (d)

Meet the Author

Active individual and professional traders.

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Table of Contents



Organization of the Book.



1. Introduction to Biopharmaceuticals.

1.1. Biotechnology versus Pharmaceutical Biotechnology.

1.2. Historical Perspective of Pharmaceutical Biotechnology.

1.3. Not All Protein Drugs and Vaccines of the Same Name Are Identical.

2. Comparative Drug Development of Proteins and Genes versus Small Molecules.

2.1. Transforming New Molecular Entities into Drugs.

2.2. Differences between Development of Biotechnology Products of Macromolecules and Chemical Products.

2.3. Current Trends in Drug Development.

3. Biotechnology Industry Perspective on Drug Development.

3.1. Introduction.

3.2. Role of the Orphan Drug Act.

3.3. Clinical Leverage Strategy in Accelerating Drug Development.

3.4. Therapeutic Target Considerations.

4. Biopharmaceutical Technologies and Processes in Drug Development.

4.1. Application of Biotechnologies in Drug Discovery and Development.

4.2. Large-Scale Production of Recombinant Proteins.

4.3. Biologic Drug Development and Approval.

5. Pharmacology, Toxicology, Therapeutic Dosage Formulations, and Clinical Response.

5.1. Clinical Pharmacology.

5.2. Dose and Therapeutic Response.

5.3. Dosage Form and Routes of Administration.


6. Hematopoietic Growth Factors and Coagulation Factors.

6.1. Overview.

6.2. Monographs.

7. Interferons and Cytokines for Anti-infective and Cancer Therapy.

7.1. Interferons in Cancer Therapy (Mamta Chawla-Sarkar, Paul Masci, and Ernest Borden).

7.2. Interferons in Viral Hepatitis (Gary L. Davis).

7.3. Interferon-b in the Treatment of Multiple Sclerosis.

7.4. Monographs.

8. Hormones.

8.1. Protein Hormones as Therapeutics:Yesterday, Today, and Tomorrow (Sandra Blethen

8.2. Monographs.

9. Enzymes.

9.1. Overview of Enzyme Therapies.

9.2. Monographs.

10. Antibodies and Derivatives.

10.1. Overview.

10.2. Monographs.

11. Vaccines (Shiu-Lok Hu and Rodney J.Y. Ho).

11.1. Why Vaccines?

11.2. How Do Vaccines Work?

11.3. Traditional Vaccine Approaches.

11.4. Subcellular and Recombinant Subunit Vaccines.

11.5. Future Directions.

11.6. Summary.

12. Other Products: Monographs.


13. Advanced Drug Delivery.

13.1. Rationale and Basic Principles.

13.2. Physiologic and Mechanistic Approaches.

13.3. Approaches Using Devices.

13.4. Molecular Approaches.

13.5. Summary.

14. Individualization of Drug Regimens: Integration of Pharmacokinetic and Pharmacogenetic Principles in Drug Therapy.

14.1. Overview of Factors Governing Interindividual Variations.

14.2. Historical Perspective on Pharmacogenetics.

14.3. Pharmacogenetics: Drug Metabolism and Transport.

14.4. Pharmacogenetics: Therapeutic Response.

14.5. Individualized Gene-Based Medicine: A Mixed Blessing.

14.6. Current and Potential Application of Pharmacogenetics.

14.7. Summary.

15. Gene and Cell Therapy.

15.1. Overview of Gene and Cell Therapeutics.

15.2. Delivery and Expression of Genes Encoded for Functional Proteins (Sean M. Sullivan).

16. Integration of Discovery and Development: The Role of Genomics and Proteomics.

16.1. Overview.

16.2. Integration of Discovery and Development of Therapeutic Candidates.

16.3. Genomics: The First Link between Sequences and Drug Targets.

16.4. Proteomics: From Sequences to Functions.

16.5. Integrating Proteomic and Genomic Tools to Accelerate Drug Development.

16.6. Summary.

Appendix I: Dosage Form, Pharmacokinetics, and Disposition Data.

Appendix II: Molecular Characteristic and Therapeutic Use.

Appendix III: Nomenclature of Biotechnology Products.

Appendix IV: Synonyms of Trade, Common, and Scientific Names.

Appendix V: Other Information Tables.


Monographs Index.

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  • Anonymous

    Posted August 5, 2003

    Useful Book

    '...faculty that teach in the pharmaceutics curriculum will find the Ho and Gibaldi text of great value as course content is revised and new areas are added and expanded. The book provides important linkages between the science and therapeutics of biotechnology products that faculty will find useful in integrating the subject matter in health sciences and graduate program curricula.' --Stuart Feldman, Ph.D., Biomedical and Health Sciences Institute and Department of Pharmaceutical and Biomedical Sciences, University of Georgia, Athens, Georgia

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