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| Applied Enzymology, an Overview | |
| Introduction | |
| Enzymes: Sources and Production | |
| Enzymes Used for Analytical Purposes | |
| Enzymes Used for Industrial Purposes | |
| The Future of Industrial Enzymes | |
| Enzyme Engineering | |
| Introduction | |
| Improving Enzymes by Engineering | |
| Engineered Enzyme Properties | |
| Engineering Therapeutic Enzymes | |
| Conclusions | |
| Tissue Plasminogen Activator-Based Thrombolytic Agents | |
| Thrombosis and Thrombolytic Therapy | |
| Alteplase | |
| Reteplase | |
| Tenecteplase | |
| Conclusions | |
| Activated Protein C | |
| 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 | |
| Introduction | |
| Biochemical Aspects | |
| Catalytic Mechanism | |
| Determination of Activity | |
| Therapeutic Applications | |
| Production and Stability of rhDNase I | |
| Prospects | |
| b-Glucocerebrosidase Ceredase“ and Cerezyme“ | |
| 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 | |
| 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 | |
| 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 | |
| Historical Background | |
| Pharmacology of L-Asp | |
| Mechanism of Action, Drug Resistance, and In Vitro Testing | |
| Clinical Applications | |
| Adverse Effects | |
| Conclusions | |
| Recombinant Factor VIIa | |
| Introduction | |
| Characteristics of the Enzyme | |
| Manufacturing Process | |
| Indications for which Factor VIIa is Approved | |
| Developmental History of the Enzyme | |
| Conclusions | |
| Factor IX (Protease Zymogen) | |
| 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) | |
| 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 | |
| Introduction | |
| Urokinase | |
| Streptokinase | |
| Staphylokinase | |
| Ancrod | |
| Acid µ-Glucosidase | |
| Superoxide Dismutase | |
| Hyaluronidase | |
| Enzymes as Digestive Aids | |
| Debriding and Anti-Inflammatory Agents | |
| Table of Contents provided by Publisher. All Rights Reserved. |
