Therapeutic Enzymes

Acid aGlucosidase
Activation of FIX Zymogen
Additional Safety Concerns
Adverse Reactions and Warnings - 2 3
Advisory Committee Preparation and Execution
Alteplase
Ancrod
Ancrod Development
Antithrombotic Activity of APC
Antithrombotic Mechanism
APC Mechanism and Sepsis
APC Mechanisms of Action
At
Biochemical Aspects
Biochemical Characteristics
Biochemical Function in GAG Metabolism
Biochemical Properties - 2
Biochemistry
Biochemistry and Genetics of Recombinant aLIduronidase - 2
C
Catalytic Activity
Catalytic Mechanism
Cell Banking and Stability of the Cell Line
Cell Culture and Perfusion Process
Cell Line Identification
Characterization of Protein and Carbohydrate
Clinical Deficiency of aLIduronidase and MPS I
Clinical Development of Drotrecogin Alfa Activated for Severe Sepsis
Clinical Evaluation 11571 Preclinical Studies
Clinical Safety
Clinical Studies - 2
Clinical Trials
Conclusions - 2 3
Contents - 2 3 4 5 6 7 8 9 10 11 12 13
Contributors
Determination of Activity
Development of an rFIX Production Line
Development of Ceredase
Development of rFVIIa as a Universal Hemostatic Agent
Development of rhAPC
Developmental History of the Enzyme 1051 Preclinical Development
Discovery of Correction In Vitro Uptake and Treatment of MPS I
Nase I in NonCF Respiratory Diseases
Nase I in Wound Healing and Cancer
Early Attempts at Therapy
Early Production of rhIDU
Early Treatments
Efficacy in Models of Ischemic Injury
Enzyme Composition Synthesis and Biochemical Action 12211 Protein and Gene Sequence and Structure
Figure 101 - 2
Figure 102
Figure 103 - 2
Figure 104
Figure 105
Figure 106
Figure 111
Figure 112 - 2
Figure 113
Figure
Figure 121
Figure 122
Figure 123
Figure 124 - 2
Figure 131
Figure 132
Figure 134
Figure 135 3 4 5
Figure 22 6 7 8 9 10 11 12 13 14 15 16
Figure 53 17 18 19 20 21 22 23 24 25
Figure 77
Figure 811 26
FIX Modification
Formulation and Administration Aspects
FVII Deficiency
Gaucher Disease
Gene Therapy for Hemophilia B
Gj Vc
Gj Vi
Glanzmanns Thrombasthenia
Hemophilia Patients with Inhibitors
High Purity pdFIX Products
Hyaluronidase
Indications for which Factor VIIa is Approved
Info - 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Intracellular Trafficking and Uptake Via M6PR
Introduction - 2
Introduction and Overview 3 4 5
K
Manifestations of the Spectrum of Mps I Disease
Manufacture and Composition - 2 3
Manufacturing Process
Mechanism of Action of rFVIIa
Mechanistic Observations from the Clinical Experience
Molecular Basis
Mutations in aLlduronidase in MPS I
N - 2
N N
NLinked Carbohydrate Structure
NLinked Glycosylation
Nonresponders and Inhibition of DNase I by Actin
Nonviral Vectors
OLinked Glycosylation
On O
Pancreatin
Pathophysiology of MPS I
Pharmacokinetics in Patients
Polymorphisms
Preface
Production and Stability of rhDNase I
Production of Acid aGlucosidase for Therapeutic
Production of Streptokinase
Prospects
Protein Domain Structure of FIX
Purification
Purification and Characterization of Recombinant Produced Human APC
Purification of Highly Purified High Uptake rhIDU
Purification of rFIX
Purity and Safety
Q
Quality Control Evaluations
Rationale and Clinical Results
Rationale for Enzyme Therapy in MPS I
Reductions in Measures of Storage
References - 2 3 4 5 6
Regulatory Approval
Regulatory Strategies and Challenges with Surrogate Endpoints
Results from Finalized Trials Outside the Current Indication
Reteplase
RFIX Biochemical Properties and Characterization
RFIX Formulation
RFIX Production Cell Line
RhAPC Derivatives
Role of Protein C Pathway in Sepsis
S
S61
Safety
Shiprec
Sources of Urokinase
Steps to Increase Safety of Blood Derived Clotting Factor Products
Streptokinase
Studies of ERT in Canine MPS I
Study Results in Reducing Lysosomal Storage
Study Results in the Clinical Manifestations
Study Results in the Primary Endpoints
Summary and Conclusions
Superoxide Dismutase
Table - 2 3 4 5 6 7 8 9
Tenecteplase
Testicular Type Hyaluronidases
Therapeutic Applications - 2 3
Therapeutic Efficacy
Therapeutic Hyaluronidases
Therapeutic Rationale for Sepsis 4431 Sepsis Pathophysiology
Therapeutic Uses
Three Dimensional Structure of FVIIa and its Relation to Function
Treatment of Hemophilia B
University of Limerick Limerick Ireland
Urokinase
Use of Clinical Endpoints in a Novel Disease Target
Viral Vectors for Hemophilia B Gene Therapy
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