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

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

by Rodney J. Y. Ho, Milo Gibaldi
     
 

The study and manipulation of life forms on the molecular level continues to set the pace in modern science and medicine. Biotechnology and Biopharmaceuticals represents a unique, textual combination of these two dynamic disciplines, focusing on the role biotechnology plays in the discovery and development of therapeutic drugs.

The first of the book’s three

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Overview

The study and manipulation of life forms on the molecular level continues to set the pace in modern science and medicine. Biotechnology and Biopharmaceuticals represents a unique, textual combination of these two dynamic disciplines, focusing on the role biotechnology plays in the discovery and development of therapeutic drugs.

The first of the book’s three sections focuses on the process of transforming a macromolecule into a therapeutic agent; the second provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. The second section also provides additional detail for each FDA approved biopharmaceutical. The final section looks to new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. Biotechnology and Biopharmaceuticals also:

  • Presents the first-ever effort to provide insight into how biologic and recombinant molecules are developed from a concept to a therapeutic product
  • Strives to provide readers with a dynamic view of the science and business aspects of developing biopharmaceuticals
  • Describes the key differences in the discovery and development of classical, small-molecule drugs and high-molecular-weight biopharmaceuticals
  • Includes information about indications, dosage, clinical pharmacology, toxicology, and therapeutic response
  • Offers discussion of cell and gene therapeutics, and genomics/proteomics for drug discovery
  • Provides an outline and content suitable for the development of courses in pharmaceutical biotechnology and biopharmaceutics

Biotechnology and Biopharmaceuticals provides an ideal resource for graduate students and undergraduates in colleges of pharmacy and health sciences, for pharmaceutical and biomedical scientists in academia and industry, and for clinical pharmacists and medical center—based clinicians.

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Product Details

ISBN-13:
9780471206903
Publisher:
Wiley
Publication date:
08/01/2003
Edition description:
New Edition
Pages:
576
Product dimensions:
7.13(w) x 10.14(h) x 1.25(d)

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Table of Contents

Foreword.

Preface.

Organization of the Book.

Contributors.

PART I: TRANSFORMING PROTEINS AND GENES INTO THERAPEUTICS.

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.

PART II: THERAPEUTICS BASED ON BIOTECHNOLOGY.

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.

PART III: FUTURE DIRECTIONS.

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.

Index.

Monographs Index.

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