McGrath / Walsh Directory of Therapeutic Enzymes

Erscheinungsjahr 2005
ISBN: 978-1-4200-3837-8
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 312 Seiten

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product. Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications. The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

Zielgruppe

Pharmaceutical professionals, biotechnologists, biochemists, graduate students in pharmacy and biotechnology

Autoren/Hrsg.

McGrath, Barry M.

Walsh, Gary

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Naturwissenschaften Biowissenschaften Biochemie (nichtmedizinisch)

Inhaltsverzeichnis

Applied Enzymology, an Overview, N. Shanley and G. Walsh

Introduction

Enzymes: Sources and Production

Enzymes Used for Analytical Purposes

Enzymes Used for Industrial Purposes

The Future of Industrial Enzymes

Enzyme Engineering, B.M. McGrath

Introduction

Improving Enzymes by Engineering

Engineered Enzyme Properties

Engineering Therapeutic Enzymes

Conclusions

Tissue Plasminogen Activator-Based Thrombolytic Agents, G. Walsh

Thrombosis and Thrombolytic Therapy

Alteplase

Reteplase

Tenecteplase

Conclusions

Activated Protein C, B.W. Grinnell, S.B. Yan, and W.L. Macias

Structure of APC

Development of rhAPC

APC Mechanisms of Action

APC Pharmacology and Therapeutic Rationale

Clinical Development of Drotrecogin Alfa (Activated) for Severe Sepsis

Summary and Conclusions

Deoxyribonuclease I, N.N. Sanders, S.C. De Smedt, and J. Demeester

Introduction

Biochemical Aspects

Catalytic Mechanism

Determination of Activity

Therapeutic Applications

Production and Stability of rhDNase I

Prospects

b-Glucocerebrosidase Ceredase ® and Cerezyme ®, T. Edmunds

Introduction

Gaucher’s Disease

Biochemistry

Early Attempts at Therapy

Development of Ceredase

Development of Cerezyme

Biochemical Comparison of Cerezyme and Ceredase

Clinical Comparisons of Cerezyme and Ceredase

Orphan Drug Development Challenges

Acknowledgements

b-Galactosidase, D. Barngrover

Introduction

Detailed Biochemical Characteristics of the Enzyme

Fabry’s Disease and the Role of Fabrazyme Enzyme Replacement Therapy

Development History of the Product

Details of Enzyme Product Manufacture

Conclusion

Acknowledgements

Urate Oxidase, A. Bayol, F. Lascombes, D. Loyaux, J.-M. Bras, G. Loison, R. Couderc, and P. Ferrara

Introduction

Biochemical Characteristics of the Enzyme

Indications for which the Enzyme is Approved

Developmental History of the Enzyme

Characteristics of the Enzyme’s Producer Cell Line

Enzyme Manufacture Process

Main Quality Control Evaluations Undertaken during Production

Final Enzyme Product Formulation

L-Asparaginase Review of Pharmacology, Drug Resistance, and Clinical Applications, C. Mauz-Körholz, V. Wahn, and D. Körholz

Historical Background

Pharmacology of L-Asp

Mechanism of Action, Drug Resistance, and In Vitro Testing

Clinical Applications

Adverse Effects

Conclusions

Recombinant Factor VIIa, E. Erhardtsen, N. Brun, N.K. Klausen, E. Persson, and P. Rexen

Introduction

Characteristics of the Enzyme

Manufacturing Process

Indications for which Factor VIIa is Approved

Developmental History of the Enzyme

Conclusions

Factor IX (Protease Zymogen), B.M. McGrath

Introduction

Biochemical Properties and Characterization of FIX

Hemophilia B

Treatment of Hemophilia B

rFIX

Gene Therapy for Hemophilia B

Conclusions

The Development of Aldurazyme® (Laronidase), E. Kakkis

Introduction and Overview

Biochemistry and Genetics of Recombinant µ-L-Iduronidase

Clinical Deficiency of µ-L-Iduronidase and MPS I

Early Development of ERT

Manufacturing of Aldurazyme for the Commercial Market

Quality Control System and Assays

Clinical Development of Aldurazyme

Additional Therapeutic Enzymes, S. O’Connell

Introduction

Urokinase

Streptokinase

Staphylokinase

Ancrod

Acid µ-Glucosidase

Superoxide Dismutase

Hyaluronidase

Enzymes as Digestive Aids

Debriding and Anti-Inflammatory Agents