Directory of Therapeutic Enzymes
Features
Summary
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.
Table of Contents
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
Editorial Reviews
“This volume covers all therapeutic enzymes currently approved for use in medicine. Written mainly by industry experts, the book includes information sourced directly form the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product. … 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.”
— In Anticancer Research, Vol. 26, 2006
"… covers in a handy and well-weighted format all the different aspects and some hot-topics of therapeutic enzymes. The book provides concise information from the view of experts in the field with fast access to recent literature."
– Gunther Juang, Germany in CHEMMEDCHEM, 3, 2008
