Vaccine Cell Substrates 2004: National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables
Gespeichert in:
Format: | Buch |
---|---|
Sprache: | English |
Veröffentlicht: |
Basel [u.a.]
Karger
2006
|
Schriftenreihe: | Developments in Biologicals
123 |
Schlagworte: | |
Online-Zugang: | Inhaltsverzeichnis |
Beschreibung: | IX, 361 S. Ill., graph. Darst. |
ISBN: | 3805579993 |
Internformat
MARC
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Datensatz im Suchindex
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adam_text | Contents
Introduction
Introduction to Vaccine Cell Substrates
R.L. Sheets
Session I
Potential Oncogenidty of Cellular
Cell Substrates: Where do we Stand after
/.
The Uptake and Fate of Exogenous Cellular
A.J. Strain
Lessons Learned from Gene Therapy Concerning and the Use of Integrating Vectors
and the Possible Risk of Insertional Oncogenesis
K. Cichutek
Adaptation of the WHO Guideline for Residual
on Continuous Cell Lines to a Limit for Oral Vaccines
J.A.
Biological Activity of Residual Cell-Substrate
K.
Panel I Discussion
Session II
Potential Oncogenicity of Viruses Latent in Cells
Molecular Methods for Virus Discovery
R.F. Jarrett, D. Johnson, K. Wilson, A. Gallagher
Significance of Retrovirus Contaminants of Cell Substrates (Abstract)
J.M. Coffin
Practical Assay Issues with the PERT/PBRT Assay
A. Chang, S. Dusing
Antibodies to SV40 in Sera from Humans and Macaques
P. Minor,
Polio Vaccines, SV40 and Human Tumours, an Update on False Positive and False Negative Results
A.G. Elmishad, M.
Panel II Discussion
VII
Session
Routine
Adventitious Agent Test Methods
R.L. Sheets
Scope and Practicality of in vivo Testing for Adventitious Agents
M.D. Whiteman
Detection of Adventitious Viruses in Biologicals
R.W. Nims
Approaches to the Release of a Master Cell Bank of PER.C6 Cells
for the Manufacture of Human Vaccines
J.A. Lewis, E.L. Brown,
Newer Molecular Approaches to Detect Known Viruses and Previously Unrecognized Viruses
in Cell Substrates
P.F. Wright
A Cell-Based Assay for Mouse
Ch.
Panel III Discussion
Session IV
Level of Assurance Provided by Guidelines, Especially
Basis for Sample Size in International Conference on Harmonization Guidances
A. Lubiniecki
The Impact of Technology on Assurance (Abstract)
W.A. Moore
Statistical Bases for Defining Level of Assurance
T. Schofield
Panel IV Discussion
Bonus Session
Experience with Novel Cell Lines
Comprehensive Characterization of the 293-ORF6 Cell Line
B.T. Butman, A. Lizonova,
Insect Cells as a New Substrate for Vaccine Production
W. Dalemans
Safety Assessment of Madin Darby Canine Kidney Cells as Vaccine Substrate
J.K. Medema, J. Meijer, A.J. Kersten, R. Horton
Tumorigenicity Assessments of PER.C6® Cells and of an Ad5-Vectored HIV-1 Vaccine Produced
on this Continuous Cell Line
B.J. Ledwith, C.L. Lanning,
Bonus Session Discussion
Session V
Bovine (and Porcine) Viruses
Bovine Serum
J.S. Robertson
Vaccine Cell Substrates
S.J. Wessman
Vin
Assays for Bovine Viruses (Abstract)
M. Wisher
Animal-Free Culture Process for Manufacture of Viral Vaccines
and Regulatory Perspectives
/.
Panel V Discussion
Session VI
Bovine Spongiform Encephalopathy
Susceptibility of Common Laboratory Fibroblasts to TSE Infection (Abstract)
S.A.
Diagnostics for TSE Agents
A.J. Raeber, B. Oesch
Production Cell Substrates and vCJD
P.D.
TSE Risk Assessment for Starting Materials Used During, or in the Manufacture of Vaccines
for Human Use
R. Bradley
Bovine Spongiform Encephalopathy (BSE) in the United States
of the Response with Suggestions for Additional Actions (Abstract)
LA. Detwiler
Panel VI Discussion
Contents
|
adam_txt |
Contents
Introduction
Introduction to Vaccine Cell Substrates
R.L. Sheets
Session I
Potential Oncogenidty of Cellular
Cell Substrates: Where do we Stand after
/.
The Uptake and Fate of Exogenous Cellular
A.J. Strain
Lessons Learned from Gene Therapy Concerning and the Use of Integrating Vectors
and the Possible Risk of Insertional Oncogenesis
K. Cichutek
Adaptation of the WHO Guideline for Residual
on Continuous Cell Lines to a Limit for Oral Vaccines
J.A.
Biological Activity of Residual Cell-Substrate
K.
Panel I Discussion
Session II
Potential Oncogenicity of Viruses Latent in Cells
Molecular Methods for Virus Discovery
R.F. Jarrett, D. Johnson, K. Wilson, A. Gallagher
Significance of Retrovirus Contaminants of Cell Substrates (Abstract)
J.M. Coffin
Practical Assay Issues with the PERT/PBRT Assay
A. Chang, S. Dusing
Antibodies to SV40 in Sera from Humans and Macaques
P. Minor,
Polio Vaccines, SV40 and Human Tumours, an Update on False Positive and False Negative Results
A.G. Elmishad, M.
Panel II Discussion
VII
Session
Routine
Adventitious Agent Test Methods
R.L. Sheets
Scope and Practicality of in vivo Testing for Adventitious Agents
M.D. Whiteman
Detection of Adventitious Viruses in Biologicals
R.W. Nims
Approaches to the Release of a Master Cell Bank of PER.C6 Cells
for the Manufacture of Human Vaccines
J.A. Lewis, E.L. Brown,
Newer Molecular Approaches to Detect Known Viruses and Previously Unrecognized Viruses
in Cell Substrates
P.F. Wright
A Cell-Based Assay for Mouse
Ch.
Panel III Discussion
Session IV
Level of Assurance Provided by Guidelines, Especially
Basis for Sample Size in International Conference on Harmonization Guidances
A. Lubiniecki
The Impact of Technology on Assurance (Abstract)
W.A. Moore
Statistical Bases for Defining Level of Assurance
T. Schofield
Panel IV Discussion
Bonus Session
Experience with Novel Cell Lines
Comprehensive Characterization of the 293-ORF6 Cell Line
B.T. Butman, A. Lizonova,
Insect Cells as a New Substrate for Vaccine Production
W. Dalemans
Safety Assessment of Madin Darby Canine Kidney Cells as Vaccine Substrate
J.K. Medema, J. Meijer, A.J. Kersten, R. Horton
Tumorigenicity Assessments of PER.C6® Cells and of an Ad5-Vectored HIV-1 Vaccine Produced
on this Continuous Cell Line
B.J. Ledwith, C.L. Lanning,
Bonus Session Discussion
Session V
Bovine (and Porcine) Viruses
Bovine Serum
J.S. Robertson
Vaccine Cell Substrates
S.J. Wessman
Vin
Assays for Bovine Viruses (Abstract)
M. Wisher
Animal-Free Culture Process for Manufacture of Viral Vaccines
and Regulatory Perspectives
/.
Panel V Discussion
Session VI
Bovine Spongiform Encephalopathy
Susceptibility of Common Laboratory Fibroblasts to TSE Infection (Abstract)
S.A.
Diagnostics for TSE Agents
A.J. Raeber, B. Oesch
Production Cell Substrates and vCJD
P.D.
TSE Risk Assessment for Starting Materials Used During, or in the Manufacture of Vaccines
for Human Use
R. Bradley
Bovine Spongiform Encephalopathy (BSE) in the United States
of the Response with Suggestions for Additional Actions (Abstract)
LA. Detwiler
Panel VI Discussion
Contents |
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institution | BVB |
isbn | 3805579993 |
language | English |
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physical | IX, 361 S. Ill., graph. Darst. |
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series | Developments in Biologicals |
series2 | Developments in Biologicals |
spelling | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables vol. eds. Rebecca Sheets ... Basel [u.a.] Karger 2006 IX, 361 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Developments in Biologicals 123 Biologisches Material (DE-588)4145633-6 gnd rswk-swf Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf Impfstoff (DE-588)4026655-2 gnd rswk-swf (DE-588)1071861417 Konferenzschrift 2004 Bethesda Md. gnd-content Biologisches Material (DE-588)4145633-6 s Impfstoff (DE-588)4026655-2 s Arzneimittelentwicklung (DE-588)4143176-5 s DE-604 Sheets, Rebecca Sonstige oth Developments in Biologicals 123 (DE-604)BV013104325 123 Digitalisierung UBRegensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014713607&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
spellingShingle | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables Developments in Biologicals Biologisches Material (DE-588)4145633-6 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd Impfstoff (DE-588)4026655-2 gnd |
subject_GND | (DE-588)4145633-6 (DE-588)4143176-5 (DE-588)4026655-2 (DE-588)1071861417 |
title | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables |
title_auth | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables |
title_exact_search | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables |
title_exact_search_txtP | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables |
title_full | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables vol. eds. Rebecca Sheets ... |
title_fullStr | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables vol. eds. Rebecca Sheets ... |
title_full_unstemmed | Vaccine Cell Substrates 2004 National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables vol. eds. Rebecca Sheets ... |
title_short | Vaccine Cell Substrates 2004 |
title_sort | vaccine cell substrates 2004 national institutes of health nih doubletree hotel rockville md usa june 29 july 1 2004 proceedings of a symposium 51 tables |
title_sub | National Institutes of Health (NIH), Doubletree Hotel, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables |
topic | Biologisches Material (DE-588)4145633-6 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd Impfstoff (DE-588)4026655-2 gnd |
topic_facet | Biologisches Material Arzneimittelentwicklung Impfstoff Konferenzschrift 2004 Bethesda Md. |
url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014713607&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
volume_link | (DE-604)BV013104325 |
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