Gene therapy technologies, applications and regulations: from laboratory to clinic
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Chichester [u.a.]
Wiley
1999
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XXVI, 411 S. Ill. |
| ISBN: | 0471967092 |
Staff View
MARC
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| 245 | 1 | 0 | |a Gene therapy technologies, applications and regulations |b from laboratory to clinic |c ed. by Anthony Meager |
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Record in the Search Index
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| adam_text | Contents
List of contributors xv
Preface xxi
1 Cationic Liposomes for Gene Therapy Applications 1
J.P. Clancy and Eric S. Sorscher
1.1 Introduction 1
1.2 Mechanism of action of cationic liposomes 1
1.3 Lipid mediated gene transfer to polarized epithelium 3
1.4 Cationic lipid drug discovery 3
1.5 Lipid retargeting 4
1.6 Plasmid modification 5
1.7 Preclinical and clinical trials 6
1.8 Regulatory issues regarding lipid DNA complexes 7
1.9 Summary 9
2 DNA Condensation and Receptor mediated Gene Transfer 13
Assent Ziady and Thomas Ferkol
2.1 Introduction 13
2.2 Receptor mediated gene transfer 14
2.2.1 Targeting ligand 16
2.2.1.1 Asialoglycoprotein receptor 16
2.2.1.2 Transferrin receptor 20
2.2.1.3 Polymeric immunoglobulin receptor 21
2.2.1.4 Mannose receptor 22
2.2.2 DNA condensation and complex formation 23
2.2.3 Endosomal trafficking and escape 25
2.2.4 Nuclear targeting and translocation 27
2.3 Conclusions 28
3 Retroviral Vectors 35
Walter H. Gilnzburg and Brian Salmons
3.1 Introduction 35
3.2 The retroviral replication cycle 36
3.2.1 Early events 36
3.2.2 Integration of viral DNA into host genomic DNA 36
3.2.3 Transcription, translation andassembly 38
vi CONTENTS
3.3 Retroviral vector development 39
3.3.1 Principles 40
3.3.2 Improvements 41
3.4 Infection targeting 43
3.5 Gene expression from retroviral vectors 45
3.5.1 General considerations 45
3.5.2 Expression targeting 48
3.5.3 Inducible expression 48
3.6 Retoviral vector titres and stability 49
3.7 Lentiviral vectors 52
3.8 Conclusions and perspectives 53
4 Lentiviral Vectors 61
Andrew M.L. Lever
4.1 Introduction 61
4.2 Genetic structure of lentiviruses 62
4.2.1 Advantages of lentiviral vectors 67
4.2.2 Disavantages of lentiviral vectors 67
4.3 Lentivirus based vectors 67
4.3.1 Other influences on packaging 68
4.3.2 Direct gene transfer 70
4.3.3 Helper virus mediated 70
4.3.4 Co transfection systems 71
4.3.4.1 Envelope complementation 71
4.3.4.2 Co transfection using independent vector and
packaging constructs 71
4.3.4.3 Three plasmid co transfections 76
4.3.5 Packaging cell lines 78
4.3.5.1 Problem proteins 79
4.3.5.2 Inducible constructs 80
4.3.6 Envelope pseudotyping 80
4.3.7 Protein delivery 81
4.3.8 Viral titres 81
4.4 Range of applications 82
4.5 Safety 82
5 Adenoviral Vectors 87
Sheila Connelly
5.1 Introduction 87
5.2 Structure and genomic organization of human adenoviruses 88
5.3 Design and construction of replication defective human
adenoviral vectors 90
CONTENTS vii
5.4 Propagation and purification of adenoviral vectors 94
5.5 In vivo adenovirus mediated gene transfer 95
5.6 Circumventing the host immune response to in vivo
adenoviral gene transfer 97
5.7 Summary 99
6 Adeno associated Viral Vectors 109
Terence R. Flotte and Barrie J. Carter
6.1 Introduction 109
6.2 Biology of AAV 109
6.2.1 AAV taxonomy and natural history 109
6.2.2 The structure of AAV and its genome 110
6.2.3 The AAV life cycle 112
6.2.4 Site specificity of AAV integration 113
6.3 AAV derived recombinant vectors 114
6.3.1 Structure of recombinant AAV vectors 114
6.3.2 Strategies for packaging AAV recombinant vectors 114
6.3.3 Persistence of vector DNA in target cells 116
6.3.4 Host cell factors affecting AAV vector
transduction 116
6.3.5 Summary of advantages and disadvantages of
AAV transducing vectors 117
6.4 Applications of AAV vectors 117
6.4.1 In vitro applications 118
6.4.2 In vivo applications 120
6.5 Safety issues 120
6.5.1 Subject safety 120
6.5.2 Environmental safety 121
7 Advances in Engineering HSV Vectors for Gene Transfer
to the Nervous System 127
M. Karina Soares, William F. Goins, Joseph C. Glorioso and
David J. Fink
7.1 Introduction 127
7.2 HSV biology 129
7.3 Development of HSV vectors for the nervous system 131
7.3.1 Deletion of accessory functions to increase the capacity
for foreign genes 132
7.3.2 Vector associated cytotoxicity 133
7.3.3 Promoter systems for transgene expression 136
7.3.3.1 Transient expression 137
7.3.3.2 Long term expression 138
7.3.3.3 Regulated transgene expression 142
viii CONTENTS
7.3.4 HSV amplicons 143
7.3.5 Novel hybrid HSV AAV vectors 144
7.4 Summary and future directions 144
8 Mammalian Artificial Chromosomes: Prospects for
Gene Therapy 165
Tom A. Ebersole and Christine J. Fair
8.1 Introduction 165
8.2 Why build a MAC? 165
8.3 The ideal MAC 166
8.4 Strategies for generating a MAC 167
8.4.1 The top down approach 168
8.4.2 The bottom up approach 171
8.5 Practical problems and unknowns 173
8.6 Concluding remarks 174
9 Gene Therapy for Severe Combined Immunodeficiency 179
Adrian J. Thrasher, Hubert B. Gaspar and
Christine Kinnon
9.1 Introduction 179
9.2 Molecular pathology of SCID 179
9.2.1 X linked severe combined immunodeficiency 180
9.2.2 JAK 3 defects 180
9.2.3 Adenosine deaminase and purine nucleoside
phosphorylase deficiencies 181
9.2.4 Recombinant activating genes (RAG1 and RAG2)
defects 181
9.2.5 ZAP 70 defects 181
9.2.6 MHC class I deficiency (type 1 bare lymphocyte
syndrome) 181
9.2.7 MHC class II deficiency (type 2 bare lymphocyte
syndrome) 182
9.2.8 TCR CD3 abnormalities 182
9.3 Somatic gene therapy for SCID 182
9.3.1 Clinical gene therapy for ADA SCID 183
9.3.2 T lymphocyte gene therapy for ADA SCID 184
9.3.3 Stem cell gene therapy for ADA SCID 185
9.3.4 Limiting factors for stem cell gene therapy 186
9.4 Alternative vector systems 186
9.5 Pre clinical assessment of haematopoietic stem cell
gene transfer 187
9.6 Conclusions 187
CONTENTS ix
10 Gene Therapy for Haemophilia 195
Rob C. Hoeben, Frederik H.E. Schagen, Marjolijn M. van der Eb,
Frits J. Fallaux, Alex J. van der Eb and Hans van Ormondt
10.1 Introduction 195
10.2 Gene therapy for haemophilia A 196
10.2.1 Properties of factor VIII 196
10.2.2 Ex vivo gene therapy: problems with retroviral vectors 196
10.2.3 Implantation of retrovirally transduced cells 199
10.2.4 In vivo gene therapy: encouraging results with
adenoviral vectors 200
10.3 Gene therapy for haemophilia B 201
10.4 Where do we go from here? 202
11 Cystic Fibrosis: Gene Therapy Approaches 207
Natasha J. Caplen
11.1 Introduction 207
11.2 The genetics of cystic fibrosis 207
11.3 CFTR protein and disease pathology 208
11.4 Treatment for cystic fibrosis 209
11.5 Gene transfer systems and cystic fibrosis 209
11.5.1 Background 209
11.5.2 Retroviral mediated gene transfer 210
11.5.3 Adenoviral mediated gene transfer 211
11.5.4 Adeno associated viral mediated gene transfer 214
11.5.5 Cationic lipid mediated gene transfer 215
11.5.6 Other gene transfer systems 217
11.6 Gene tansfer and CF: will it work? 218
12 Therapeutic Approaches to Haemoglobinopathies 227
Ypes Beuzard
12.1 Introduction 227
12.2 Globin retoviral vector 229
12.3 Adeno associated viral vectors 231
12.4 Homologous recombination and repair 232
12.5 Indirect gene therapies for ft thalassaemia 232
12.5.1 Correction of abnormal splicing 233
12.5.2 Activation of compensating genes 233
12.5.3 Erythropoietin gene transfer 233
12.5.4 Reduction of a globin gene expression 234
12.5.5 Other therapeutic genes 235
12.6 Sickle cell disease 236
12.7 Future prospects 236
x CONTENTS
13 Gene Therapy Approaches to Duchenne Muscular Dystrophy 243
Stephen Murphy and George Dickson
13.1 Introduction 243
13.2 Clinical and pathological features 243
13.3 The dystrophin gene and its products 244
13.4 The localisation and function of dystrophin 247
13.5 Model systems of DMD 250
13.6 Therapeutic approaches towards the treatment of DMD 251
13.7 Cell therapy for DMD: myoblast transfer 252
13.8 Gene therapies for DMD 253
13.8.1 Direct DNA injection 254
13.8.2 Retrovirus vectors 255
13.8.3 Adenovirus vectors 257
13.9 Alternative therapeutic strategies 259
13.10 Conclusions 260
14 Lysosomal Storage Diseases 267
Linda S. Lashford, Leslie }. Fairbairn and J.E. Wraith
14.1 Introduction 267
14.2 Defining the patient population 269
14.2.1 The relationship between genotype and phenotype 269
14.3 Standard and experimental treatments 271
14.3.1 Supportive care 271
14.3.2 Enzyme replacement 271
14.3.3 Bone marrow transplant 273
14.4 Tissue targets for gene therapy 275
14.4.1 Transplants of neo organs 275
14.4.2 Manipulation of primary lymphocytes 277
14.4.3 Autologous bone marrow 278
14.4.4 Direct targeting of CNS 281
14.5 Summary 284
15 Prospects for Gene Therapy of HIV Infections and AIDS 291
Caroline G.L. Lee, Michael M. Gottesman and Kuan Teh Jeang
15.1 Introduction 291
15.2 Life cycle of HIV 292
15.2.1 Receptors 293
15.2.2 Intracellular events 296
15.3 Strategies for antiviral therapy 296
15.3.1 Interference with HIV 1 replication 297
15.3.1.1 Interfering with virus entry 297
15.3.1.2 Interfering with transcription/translation
and/or virus assembly 297
CONTENTS xi
15.3.2 Induction of cell death 301
15.3.3 Immunization and augmentation of immune function 302
15.4 Delivery and selection strategies for genetic antiviral
intervention 303
16 The Development of the Regulatory Process in Europe for
Biological Medicines: how it Affects Gene Therapy Products 319
Anthony Meager, Tobias Vocke and Gerd Zimmermann
16.1 Regulation of biologies in Europe 319
16.1.1 Historical introduction 319
16.1.2 Classification and characteristics of biologies 322
16.1.3 The emergence of genetic medicines: are they
biologies? 323
16.2 Guidance for manufacturers and regulatory procedures
applying to biological medicines in Europe 325
16.3 Developments in quality assurance for biologies:
application to gene therapy products 330
16.4 Quality assurance issues 335
16.4.1 Stability of the expression vector 335
16.4.2 Producer cell and vector DNA 336
16.4.3 The manufacturing process 336
16.4.3.1 Cell banking system 337
16.4.3.2 Fermentation 337
16.4.3.3 Purification 338
16.4.4 Specifications and quality control 339
16.4.4.1 Safety and purity 339
16.4.4.2 Biological activity (potency) 340
16.4.4.3 Regulatory aspects, standardisation, and
batch release 341
16.5 Safety issues 342
17 Development and Regulation of Gene Therapy Drugs in
Germany 347
Klaus Cichutek
17.1 Introductory remarks 347
17.2 Definition 348
17.3 Preclinical research and development 350
17.4 Manufacture of drugs and ingredients for clinical use 352
17.5 Clinical trials of gene therapy drugs 353
17.6 On going or planned gene therapy trials in Germany 354
17.7 Involvement of the Paul Ehrlich Instirut in gene therapy 355
xii CONTENTS
18 The Transfer of Technology from the Laboratory to the Clinic: In
process Controls and Final Product Testing 359
Flavia Borellini and Jeffrey M. Ostrove
18.1 Introduction 359
18.2 Regulatory overview 360
18.3 General concepts of quality assurance and safety testing 361
18.4 Early product development 362
18.5 Establishment and testing of master cell banks and
manufacturer s working cell banks 364
18.6 Testing of the master virus bank or master seed stock 367
18.7 Testing of clinical products 368
18.8 Preclinical toxicology and pharmacokinetic studies 370
18.9 Conclusions 371
19 Good Laboratory Practice in the Research and Development
Laboratory 375
Alasdairf. Shepherd
19.1 Introduction 375
19.2 Good manufacturing practice 375
19.3 Good laboratory practice 376
19.4 Responsibility 377
19.5 Traceability 377
19.6 Documentation 378
19.7 The role of the study director 379
19.8 The role of quality assurance 380
19.9 Summary 381
20 Facilities for Large scale Production of Vectors Under GMP
Conditions 383
Janice E. Boyd
20.1 Introduction 383
20.2 Good manufacturing practice 384
20.2.1 Guidelines 384
20.2.2 Practical considerations 385
20.2.3 Manufacturing conditions 387
20.3 Manufacturing strategies 390
20.3.1 Cell culture options 391
20.3.1.1 Roller bottles 391
20.3.1.2 Costar Cellcube ® 391
20.3.1.3 Microcarriers 391
20.3.1.4 New Brunswick Celligen 392
20.3.2 Host cell banks 392
20.3.3 Virus banks 392
CONTENTS xiii
20.3.4 Viral downstream processing 393
20.3.5 Virus storage 395
20.3.6 Bacterial fermentation 394
20.3.7 Plasmid downstream processing 394
20.4 Equipment 395
20.4.1 Master validation plan 395
20.4.2 Cleaning 396
20.5 Documentation 396
20.6 Building design 398
20.7 Summary 399
Addendum 401
Index 403
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| spelling | Gene therapy technologies, applications and regulations from laboratory to clinic ed. by Anthony Meager Chichester [u.a.] Wiley 1999 XXVI, 411 S. Ill. txt rdacontent n rdamedia nc rdacarrier Biotechnology Gene therapy - Methodology Thérapie génique Gene Therapy methods Gene therapy Methode (DE-588)4038971-6 gnd rswk-swf Gentherapie (DE-588)4296957-8 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Gentherapie (DE-588)4296957-8 s Methode (DE-588)4038971-6 s DE-604 Meager, Anthony Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008202992&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Gene therapy technologies, applications and regulations from laboratory to clinic Biotechnology Gene therapy - Methodology Thérapie génique Gene Therapy methods Gene therapy Methode (DE-588)4038971-6 gnd Gentherapie (DE-588)4296957-8 gnd |
| subject_GND | (DE-588)4038971-6 (DE-588)4296957-8 (DE-588)4143413-4 |
| title | Gene therapy technologies, applications and regulations from laboratory to clinic |
| title_auth | Gene therapy technologies, applications and regulations from laboratory to clinic |
| title_exact_search | Gene therapy technologies, applications and regulations from laboratory to clinic |
| title_full | Gene therapy technologies, applications and regulations from laboratory to clinic ed. by Anthony Meager |
| title_fullStr | Gene therapy technologies, applications and regulations from laboratory to clinic ed. by Anthony Meager |
| title_full_unstemmed | Gene therapy technologies, applications and regulations from laboratory to clinic ed. by Anthony Meager |
| title_short | Gene therapy technologies, applications and regulations |
| title_sort | gene therapy technologies applications and regulations from laboratory to clinic |
| title_sub | from laboratory to clinic |
| topic | Biotechnology Gene therapy - Methodology Thérapie génique Gene Therapy methods Gene therapy Methode (DE-588)4038971-6 gnd Gentherapie (DE-588)4296957-8 gnd |
| topic_facet | Biotechnology Gene therapy - Methodology Thérapie génique Gene Therapy methods Gene therapy Methode Gentherapie Aufsatzsammlung |
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