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Title:
Biotechnology and biopharmaceuticals : transforming proteins and genes into drugs
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Publication Information:
Hoboken, N.J. : John Wiley & Sons, 2003
ISBN:
9780471206903
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30000010052280 RS380 H67 2003 Open Access Book Book
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Summary

Summary

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.


Author Notes

Rodney J.Y. Ho, Ph.D.: University of Washington School of Pharmacy, Department of Pharmaceutics, Seattle
Milo Gibaldi, Ph.D.: University of Washington School of Pharmacy, Department of Pharmaceutics, Seattle


Table of Contents

Mamta Chawla-Sarkar and Paul Masci and Ernest BordenGary L. DavisSandra BlethenShiu-Lok Hu and Rodney J.Y. HoSean M. Sullivan
Forewordp. xi
Prefacep. xiii
Organization of the Bookp. xv
Contributorsp. xvii
Part I Transforming Proteins and Genes into Therapeuticsp. 1
1 Introduction to Biopharmaceuticalsp. 3
1.1. Biotechnology versus Pharmaceutical Biotechnologyp. 5
1.2. Historical Perspective of Pharmaceutical Biotechnologyp. 6
1.3. Not All Protein Drugs and Vaccines of the Same Name Are Identicalp. 7
2 Comparative Drug Development of Proteins and Genes versus Small Moleculesp. 11
2.1. Transforming New Molecular Entities into Drugsp. 12
2.2. Differences between Development of Biotechnology Products of Macromolecules and Chemical Productsp. 15
2.3. Current Trends in Drug Developmentp. 18
3 Biotechnology Industry Perspective on Drug Developmentp. 21
3.1. Introductionp. 21
3.2. Role of the Orphan Drug Actp. 25
3.3. Clinical Leverage Strategy in Accelerating Drug Developmentp. 28
3.4. Therapeutic Target Considerationsp. 28
4 Biopharmaceutical Technologies and Processes in Drug Developmentp. 35
4.1. Application of Biotechnologies in Drug Discovery and Developmentp. 35
4.2. Large-Scale Production of Recombinant Proteinsp. 63
4.3. Biologic Drug Development and Approvalp. 80
5 Pharmacology, Toxicology, Therapeutic Dosage Formulations, and Clinical Responsep. 97
5.1. Clinical Pharmacologyp. 98
5.2. Dose and Therapeutic Responsep. 116
5.3. Dosage Form and Routes of Administrationp. 118
Part II Therapeutics Based on Biotechnologyp. 125
6 Hematopoietic Growth Factors and Coagulation Factorsp. 127
6.1. Overviewp. 128
6.2. Monographsp. 136
7 Interferons and Cytokines for Anti-infective and Cancer Therapyp. 161
7.1. Interferons in Cancer Therapyp. 161
7.2. Interferons in Viral Hepatitisp. 179
7.3. Interferon-[beta] in the Treatment of Multiple Sclerosisp. 185
7.4. Monographsp. 188
8 Hormonesp. 209
8.1. Protein Hormones as Therapeutics: Yesterday, Today, and Tomorrowp. 209
8.2. Monographsp. 215
9 Enzymesp. 245
9.1. Overview of Enzyme Therapiesp. 245
9.2. Monographsp. 256
10 Antibodies and Derivativesp. 271
10.1. Overviewp. 271
10.2. Monographsp. 289
11 Vaccinesp. 313
11.1. Why Vaccines?p. 313
11.2. How Do Vaccines Work?p. 314
11.3. Traditional Vaccine Approachesp. 315
11.4. Subcellular and Recombinant Subunit Vaccinesp. 316
11.5. Future Directionsp. 323
11.6. Summaryp. 323
12 Other Products: Monographsp. 331
Part III Future Directionsp. 337
13 Advanced Drug Deliveryp. 339
13.1. Rationale and Basic Principlesp. 339
13.2. Physiologic and Mechanistic Approachesp. 345
13.3. Approaches Using Devicesp. 367
13.4. Molecular Approachesp. 369
13.5. Summaryp. 374
14 Individualization of Drug Regimens: Integration of Pharmacokinetic and Pharmacogenetic Principles in Drug Therapyp. 381
14.1. Overview of Factors Governing Interindividual Variationsp. 381
14.2. Historical Perspective on Pharmacogeneticsp. 382
14.3. Pharmacogenetics: Drug Metabolism and Transportp. 386
14.4. Pharmacogenetics: Therapeutic Responsep. 391
14.5. Individualized Gene-Based Medicine: A Mixed Blessingp. 395
14.6. Current and Potential Application of Pharmacogeneticsp. 396
14.7. Summaryp. 398
15 Gene and Cell Therapyp. 401
15.1. Overview of Gene and Cell Therapeuticsp. 401
15.2. Delivery and Expression of Genes Encoded for Functional Proteinsp. 412
16 Integration of Discovery and Development: The Role of Genomics and Proteomicsp. 427
16.1. Overviewp. 427
16.2. Integration of Discovery and Development of Therapeutic Candidatesp. 429
16.3. Genomics: The First Link between Sequences and Drug Targetsp. 430
16.4. Proteomics: From Sequences to Functionsp. 433
16.5. Integrating Proteomic and Genomic Tools to Accelerate Drug Developmentp. 437
16.6. Summaryp. 443
Appendix I Dosage Form, Pharmacokinetics, and Disposition Datap. 445
Appendix II Molecular Characteristic and Therapeutic Usep. 467
Appendix III Nomenclature of Biotechnology Productsp. 495
Appendix IV Synonyms of Trade, Common, and Scientific Namesp. 499
Appendix V Other Information Tablesp. 527
Indexp. 539
Monographs Indexp. 555