Directory of Therapeutic Enzymes

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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.

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Editorial Reviews

Doody's Review Service
Reviewer: Eugene A Davidson, PhD (Georgetown University School of Medicine)
Description: This book covers enzymes currently in clinical use. The chapters are somewhat descriptive; each has a suitable bibliography.
Purpose: The goal is to provide an overview of enzymes in clinical use with a focus on recombinant production. Certain commonalities limit the scope of the volume although issues discussed are of interest to the commercial producer. Success in meeting stated goals is limited.
Audience: The target audience includes those in the industrial laboratory/production facility responsible for manufacturing materials of this type. The general principles of production of recombinant material for human use are of importance — hopefully, those already doing such work are well aware of them. The contributing authors are mainly from European pharmaceutical companies and presumably are knowledgeable in the area.
Features: Two introductory chapters, one an overview and one discussing enzyme engineering, are followed by a set of descriptions of current production of therapeutic enzymes. The enzyme engineering factor covers issues such as stability, improvement of interaction with inhibitors (by specific amino acid changes), the role of glycosylation stability problems etc. These are important considerations for production and efficacy, but it must be recognized that each protein product will have its own challenge in this arena. Thus, an enzyme destined for lysosomal function must have the proper glycosylation signal while one intended for extended lifetime may require attachment of polyethylene glycol. Each of the chapters dealing with specific enzymes (10 in all) describes challenges in production for human use of the particular product. Useful bibliographies accompany each chapter. There is a significant amount of repetition both in text and figures (how many photos of a fermenter are required?), indicative of common problems in production. Perhaps repetition in this area is valuable. A concluding chapter provides brief information on a variety of products not generally recombinant but still with clinical utility (streptokinase, hyaluronidase, lactase, for example).
Assessment: This is a book of limited use — the production staff will know the issues (or should). Each protein has its own characteristic problems and will require an individualized solution. Those not in production but rather in the academic arena will find instructive material here. The book suffers from repetition.
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Product Details

  • ISBN-13: 9780849327148
  • Publisher: Taylor & Francis
  • Publication date: 8/19/2005
  • Pages: 312
  • Product dimensions: 7.10 (w) x 10.00 (h) x 0.90 (d)

Table of Contents

Applied Enzymology, an Overview, N. Shanley and G. Walsh
Enzymes: Sources and Production
Enzymes Used for Analytical Purposes
Enzymes Used for Industrial Purposes
The Future of Industrial Enzymes
Enzyme Engineering, B.M. McGrath
Improving Enzymes by Engineering
Engineered Enzyme Properties
Engineering Therapeutic Enzymes
Tissue Plasminogen Activator-Based Thrombolytic Agents, G. Walsh
Thrombosis and Thrombolytic Therapy
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
Biochemical Aspects
Catalytic Mechanism
Determination of Activity
Therapeutic Applications
Production and Stability of rhDNase I
Prospects b-Glucocerebrosidase Ceredase ® and Cerezyme ®, T. Edmunds
Gaucher’s Disease
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
b-Galactosidase, D. Barngrover
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
Urate Oxidase, A. Bayol, F. Lascombes, D. Loyaux, J.-M. Bras, G. Loison, R. Couderc, and P. Ferrara
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
Recombinant Factor VIIa, E. Erhardtsen, N. Brun, N.K. Klausen, E. Persson, and P. Rexen
Characteristics of the Enzyme
Manufacturing Process
Indications for which Factor VIIa is Approved
Developmental History of the Enzyme
Factor IX (Protease Zymogen), B.M. McGrath
Biochemical Properties and Characterization of FIX
Hemophilia B
Treatment of Hemophilia B
Gene Therapy for Hemophilia B
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
Acid µ-Glucosidase
Superoxide Dismutase
Enzymes as Digestive Aids
Debriding and Anti-Inflammatory Agents

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