Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones: Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables
Gespeichert in:
Format: | Buch |
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Sprache: | English |
Veröffentlicht: |
Basel [u.a.]
Karger
2002
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Schriftenreihe: | Developments in biologicals
111 |
Schlagworte: | |
Online-Zugang: | Inhaltsverzeichnis |
Beschreibung: | Literaturangaben |
Beschreibung: | XI, 340 S. Ill., graph. Darst. |
ISBN: | 3805575092 |
Internformat
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245 | 1 | 0 | |a Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones |b Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables |c organized by the National Institute of Public Health and the Environment (RIVM, NL). Vol. ed.: Fred Brown |
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Datensatz im Suchindex
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adam_text | Contents
Opening Session
Progress in Applying the Three Rs of Russell Burch to the Testing of Biological Products ... 3
M. Balls, M. Haider
Regulatory Processes and Three Rs Alternatives 15
J. Milstien
Session I
The Three Rs and Safety Testing: Current Activities 21
Chair: P. van der Valk (FEDESA, B)
Use of PCR for Extranous Agent Testing in Avian Vaccines 23
H.P. Ottiger
In vitro Determination of Specific Toxicity in Tetanus Vaccine 27
B. Kegel, U. Bonifas, K. Silberbach, B. Kramer, K. Weisser
Session II
Potency Testing and the Three Rs: Current Activities 35
Chair: /. Claassen (ID Lelystad, NL)
Development of an In vitro Potency Test for Tetanus Vaccines: An Immunoassay Based on He
Fragment Determination 37
S. Prieur, S. Broc, M. Gal, B. Poirier, F. Fuchs
Toxicity and Immunogenicity of Pertussis Whole Cell Vaccine in one Animal Model 47
/. van Straaten, L. Levels, A. van der Ark, M. Thalen, C. Hendriksen
Developments in Reduction and Replacement of In vivo Toxicity and Potency Tests for Pertussis
Vaccines 57
D.K.L. Xing, C. Canthaboo, A. Douglas Bardsley, C.T. Yuen, S. Prior, Y. Liu, M.J. Corbel
Collaborative Study for the Establishment of Two European Pharmacopoeia Biological Reference
Preparations for Serological Potency Testing of Tetanus Vaccines for Veterinary Use 69
H.H. Lensing, M.E. Behr Gross, A. Daas, J.M. Spieser
Session HI
Testing of Hormones 77
Chair: /. Mulders (Organon, NL)
Progress and Problems in the Replacement of In vivo Pharmacopoeial Bioassays for Hormones ... 79
A.F. Bristow, E. Charton
N Glycan Charge Assay An Alternative for Potency Assays of Therapeutic Glycoproteins ? .... 89
P. Hermentin, R. Witzel, P. Schwick Wagner, M. Blumrich
IX
Session IV
Other Biologicals 99
Chair: K. Weisser (PEI, D)
Alternatives in Testing of Bacterial Toxins and Antitoxins 101
D. Sesardic
Replacement of Murine Sera by Allergen Specific Monoclonal IgE Antibodies: A New Approach
for the Characterisation of Allergen Extracts 109
5. Kaul, K. Fotisch, F. Karamloo, S. Vieths, A. Hoffmann
Evaluation of the Toxicity of Recombinant Bordetella pertussis Adenylate Cyclase Toxin
Preparations 117
5. Prior, D.K.L. Xing, G. Auda, M.J. Corbel
Session V
Ongoing Validation Studies: Case Reports 129
Chair: L. Bruckner (IVI, CH)
Serological Methods for Potency Testing of Tetanus Toxoid Vaccines for Human Use 131
C. Hendriksen, R. Winsnes
A Vero Cell Method for Potency Testing of Diphtheria Vaccines 141
R. Winsnes, D. Sesardic, A. Daas, P. Rigsby
An ECVAM Pre Validation Study of Physicochemical Methods for Predicting the Biological
Potency of Recombinant Follicle Stimulating Hormone 149
PL. Starring, R.E. Gaines Das, J.W.M. Mulders, M. Haider
Batch Potency Testing of Inactivated Erysipelas Vaccines by ELISA Development, Validation and
Implementation ¦ 153
U. Rosskopf Streicher, S. Johannes, H. Gyra, R. Beckmann, K. Cussler
Potency Testing of Inactivated Erysipelas Vaccines by ELISA Influence of the Adjuvant on
Antibody Development 159
U. Rosskopf Streicher, S. Johannes, K. Cussler
Validation of a Candidate In vitro Potency Assay for Inactivated Newcastle Disease Vaccines 163
R. Maas, M. Komen, H. Oei, I. Claassen
Collaborative Study for the Establishment of a European Pharmacopoeia Biological Reference
Preparation for Clostridia Antiserum for Serological Potency Testing of Veterinary Clostridial
Vaccines 171
R. Lucken, A. Daas, M.E. Behr Gross
Comparison and Validation of Novel Pyrogen Tests Based on the Human Fever Reaction 181
5. Schindler, T. Hartung and the Human(e) Pyrogen Test Study Group
Session VI
Implementation of Three Rs Alternatives in Regulatory Testing: Possibilities
and Obstacles 187
Chair: D. Stainer (Stainer Associates, CDN)
A View from Industry 189
M.L. Chapek
Adoption of Three Rs Alternatives for Regulatory Testing of Vaccines in the Developing World:
Possibilities and Barriers 195
J.L Di Fabio, M.T. Jaramillo, J.L. Arciniega
Implementation of Three Rs Alternatives in Regulatory Testing: Possibilities and Obstacles
The View of the Validator 199
M. Haider, M. Balls
Implementation of the Three Rs in Regulatory Testing of Vaccines in Canada 207
G.A. Culver
Animal Pain and Distress in Vaccine Testing in the United States 213
M.L. Stephens, G.M. Alvino, J.B. Branson
X Contents
Workshop Session
New Vaccine Production Technologies and their Impact on the Use of Animals 219
P.P. Pastoret, R. Sitrin
Best Animal Care Practices in the Production and Control of Biologicals 221
D.B. Morton, E. Hanenberg
Implementation of Three Rs Methods in 3rdWorld Countries 227
J.L. Di Fabio, J. Milstien
Session VII
Replacement in Vaccine Production and the Use of Serum Free Media 231
Chair: C. Beuvery (RIVM, NL)
Development of Serum Free Media for Cell Growth and Production of Viruses/Viral Vaccines
Safety Issues of Animal Products Used in Serum Free Media 233
O. W.Merten
Standardisation of Cell Lines 259
G.N. Stacey
Advanced Process Monitoring: the Ultimate Alternative 273
R. Neeleman, C. Beuvery
Session VIII
New Approaches in Vaccines Development and in Vaccine Quality Control 283
Chair: P.P. Pastoret (University de Liege, B)
New Vaccine Technologies 285
D.J. Wood
Consistency Testing of Diphtheria and Tetanus to Replace Potency Testing for Lot Release 291
J.G. Kreeftenberg
In vitro Versus In vivo Concordance: A Case Study of the Replacement of an Animal Potency
Test with an Immunochemical Assay 299
T. Schofield
Validation of an in vitro Potency Test for the Cuban Hepatitis B Vaccine 305
M. Landys Chovel Cuervo, N. Reyes Huerta
Antigen Content of Inactivated Newcastle Disease Oil Emulsion Vaccines as an In vitro Indicator
of Potency 313
R. Maas, M. van Diepen, M. Komen, H. Oei, I. Claassen
Session IX
New Quality Control Techniques 319
Chair: H. Kreeftenberg (RIVM, NL)
Novel In vitro Functional Assays for the Determination of Anthrax Toxin Components 321
B. Hallis, N.J. Silman. S. Noonan, R. Baker. A.D.G. Roberts. C.P. Quinn. T. Marks, C. Wiblin.
G. Llovd, A. Robinson, M.J. Hudson
Application of an In vitro Endopeptidase Assay for Detection of Residual Toxin Activity
in Tetanus Toxoids 327
T. Leung, P.H. Corran, C. Gee. T.A.N. Ekong. D. Sesardic
Contents *
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spelling | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables organized by the National Institute of Public Health and the Environment (RIVM, NL). Vol. ed.: Fred Brown Basel [u.a.] Karger 2002 XI, 340 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Developments in biologicals 111 Literaturangaben Impfstoff (DE-588)4026655-2 gnd rswk-swf Alternative (DE-588)4138905-0 gnd rswk-swf Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Tierversuch (DE-588)4060137-7 gnd rswk-swf (DE-588)1071861417 Konferenzschrift 2001 Utrecht gnd-content Impfstoff (DE-588)4026655-2 s Arzneimittelprüfung (DE-588)4128030-1 s Tierversuch (DE-588)4060137-7 s Alternative (DE-588)4138905-0 s DE-604 Brown, Fred 1925-2004 Sonstige (DE-588)171991923 oth Rijksinstituut voor Volksgezondheid en Milieu Sonstige (DE-588)5165952-9 oth Developments in biologicals 111 (DE-604)BV013104325 111 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010225178&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
spellingShingle | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables Developments in biologicals Impfstoff (DE-588)4026655-2 gnd Alternative (DE-588)4138905-0 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Tierversuch (DE-588)4060137-7 gnd |
subject_GND | (DE-588)4026655-2 (DE-588)4138905-0 (DE-588)4128030-1 (DE-588)4060137-7 (DE-588)1071861417 |
title | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables |
title_auth | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables |
title_exact_search | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables |
title_full | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables organized by the National Institute of Public Health and the Environment (RIVM, NL). Vol. ed.: Fred Brown |
title_fullStr | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables organized by the National Institute of Public Health and the Environment (RIVM, NL). Vol. ed.: Fred Brown |
title_full_unstemmed | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables organized by the National Institute of Public Health and the Environment (RIVM, NL). Vol. ed.: Fred Brown |
title_short | Advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones |
title_sort | advancing science and elimination of the use of laboratory animals for development and control of vaccines and hormones jaarbeurs congress centre utrecht the netherlands november 12 14 2001 proceedings of a symposium 54 tables |
title_sub | Jaarbeurs Congress Centre, Utrecht, The Netherlands, November 12 - 14, 2001 ; proceedings of a symposium ; 54 tables |
topic | Impfstoff (DE-588)4026655-2 gnd Alternative (DE-588)4138905-0 gnd Arzneimittelprüfung (DE-588)4128030-1 gnd Tierversuch (DE-588)4060137-7 gnd |
topic_facet | Impfstoff Alternative Arzneimittelprüfung Tierversuch Konferenzschrift 2001 Utrecht |
url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010225178&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
volume_link | (DE-604)BV013104325 |
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