Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals: viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Basel [u.a.]
Karger
1999
|
| Schriftenreihe: | Developments in biological standardization
99 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Literaturangaben |
| Beschreibung: | VIII, 203 S. Ill., graph. Darst. |
| ISBN: | 3805568061 |
Internformat
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Datensatz im Suchindex
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| adam_text | Contents
Session I
Benefits and Risks of Serum Use (1) 1
Chairpersons: G. Vicari (Istituto Superiore di Sanitd, Roma, Italy)
D. Espeseth (USDA APHIS VS Center for Veterinary Biologies,
Riverdale, MD, USA)
Benefits and Risks Due to Animal Serum Used in Cell Culture Production 3
S.J. Wessman, R.L. Levings
Risks of Virus Transmission Associated with Animal Sera or Substitutes and Methods of Control 9
M. Eloit
Why Do we Still Use Serum in the Production of Biopharmaceuticals? 17
G. Shah
Session II
Benefits and Risks of Serum Use (2) 23
Chairpersons: G. Schild (N.I.B.S.C., Potters Bar, U.K.)
T. Hayakawa (National Institute of Health Sciences,
Tokyo, Japan)
Transmissible Spongiform Encephalopathy Agents and Animal Sera 25
D. Dormont
BSE Transmission Studies with Particular Reference to Blood 35
R. Bradley
Bovine Sera Used in the Manufacture of Biologicals: Current Concerns and Policies of the
US Food and Drug Administration Regarding the Transmissible Spongiform Encephalopathies 41
D.M. Asher
Bovine Polyomavirus, a Frequent Contaminant of Calf Sera 45
J. van der Noordaa, C.J.A. Sol, R. Schuurman
Session III
Practicalities of Serum Production and Testing 49
Chairpersons: D. Asher (CBER/FDA, Rockville, MD, USA)
J.H. Trouvin (Agence du Medicament, Paris, France)
Detecting Viruses in Sera: Methods Used and their Merits 51
A. Jennings
Quality Control of Bovine Serum Used for Vaccine Production 61
J.C. Mareschal
VII
Session IV
Minimizing the Risk at Source Selective Sourcing of Serum 69
Chairpersons: P. Castle (EDQM, Strasbourg, France)
T. Cartwright (TCS, Botolph Claydon, U.K.)
Serum Supply: Policies and Controls Operating in New Zealand 71
C. Shailer, K. Corrin
Bovine Serum: Reducing the Variables through the Use of Donor Herds 79
W.B.R. Rolleston
Session V
Virus Removal and Inactivation Procedure 87
Chairpersons: F. Brown (Plum Island Animal Disease Center, Greenport, NY, USA)
J. Lower (Paul Ehrlich Institute, Langen, Germany)
Virus Removal by Filtration 89
E.G. Graf, E. Jander, A. West, H. Pora, H. Aranha Creado
Gamma Irradiation of Bovine Sera 95
M.Z. Plavsic, J.P. Daley, D.J. Danner, D.J. Weppner
Efficient Inactivation of Viruses and Mycoplasma in Animal Sera Using UVC Irradiation .... Ill
J. Kurth, R. Waldmann, J. Heith, K. Mausbach, R. Burian
A Universal Virus Inactivant for Decontaminating Blood and Biopharmaceutical Products 119
F. Brown, R.F. Meyer, M. Law, E. Kramer, J.F.E. Newman
Serum and Serum Substitutes: Virus Safety by Inactivation or Removal 131
H. Willkommen, H. Scheiblauer, J. Lower
Viral Validation Design of a Manufacturing Process 139
D. Larzul
Session VI
Elimination of Serum from Cell Culture Medium 151
Chairpersons: A. Lubiniecki (SmithKline Beecham Pharmaceuticals,
King of Prussia, PA, USA)
J. van der Noordaa (University of Amsterdam, the Netherlands)
Elimination of Serum from Cell Culture Medium 153
A.S. Lubiniecki
The Development, Benefits and Disadvantages of Serum Free Media 157
S.J. Fraud
Safety Issues of Animal Products Used in Serum Free Media 167
O.W. Merten
An Animal Origin Perspective of Common Constituents of Serum Free Medium Formulations 181
D.W.Jayme
Summary and Conclusion 189
Animal Sera, Animal Sera Derivatives and Substitutes Used in the Manufacture of Phar¬
maceuticals 191
P. Castle, J.S. Robertson
|
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| series2 | Developments in biological standardization |
| spelling | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables organized jointly by the European Department for the Quality of Medicines (EDQM) of the Council of Europe and the International Association for Biologicals (IABS) Basel [u.a.] Karger 1999 VIII, 203 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Developments in biological standardization 99 Literaturangaben Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf Mikrobielle Kontamination (DE-588)4169805-8 gnd rswk-swf Herstellung (DE-588)4159653-5 gnd rswk-swf Blutserum (DE-588)4146088-1 gnd rswk-swf Tierisches Produkt (DE-588)4126999-8 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Antiserum (DE-588)4142741-5 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content (DE-588)1071861417 Konferenzschrift gnd-content Antiserum (DE-588)4142741-5 s Arzneimittelsicherheit (DE-588)4143182-0 s DE-604 Arzneimittel (DE-588)4003115-9 s Herstellung (DE-588)4159653-5 s Blutserum (DE-588)4146088-1 s Tierisches Produkt (DE-588)4126999-8 s Mikrobielle Kontamination (DE-588)4169805-8 s Brown, Fred 1925-2004 Sonstige (DE-588)171991923 oth Developments in biological standardization 99 (DE-604)BV000000884 99 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008602860&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables Developments in biological standardization Arzneimittelsicherheit (DE-588)4143182-0 gnd Mikrobielle Kontamination (DE-588)4169805-8 gnd Herstellung (DE-588)4159653-5 gnd Blutserum (DE-588)4146088-1 gnd Tierisches Produkt (DE-588)4126999-8 gnd Arzneimittel (DE-588)4003115-9 gnd Antiserum (DE-588)4142741-5 gnd |
| subject_GND | (DE-588)4143182-0 (DE-588)4169805-8 (DE-588)4159653-5 (DE-588)4146088-1 (DE-588)4126999-8 (DE-588)4003115-9 (DE-588)4142741-5 (DE-588)4143413-4 (DE-588)1071861417 |
| title | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables |
| title_auth | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables |
| title_exact_search | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables |
| title_full | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables organized jointly by the European Department for the Quality of Medicines (EDQM) of the Council of Europe and the International Association for Biologicals (IABS) |
| title_fullStr | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables organized jointly by the European Department for the Quality of Medicines (EDQM) of the Council of Europe and the International Association for Biologicals (IABS) |
| title_full_unstemmed | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables organized jointly by the European Department for the Quality of Medicines (EDQM) of the Council of Europe and the International Association for Biologicals (IABS) |
| title_short | Animal sera, animal sera derivatives and substitutes used in the manufacture of pharmaceuticals |
| title_sort | animal sera animal sera derivatives and substitutes used in the manufacture of pharmaceuticals viral safety and regulatory aspects proceedings of a symposium strasbourg france may 5 6 1998 50 tables |
| title_sub | viral safety and regulatory aspects ; proceedings of a symposium, Strasbourg, France, May 5 - 6, 1998 ; 50 tables |
| topic | Arzneimittelsicherheit (DE-588)4143182-0 gnd Mikrobielle Kontamination (DE-588)4169805-8 gnd Herstellung (DE-588)4159653-5 gnd Blutserum (DE-588)4146088-1 gnd Tierisches Produkt (DE-588)4126999-8 gnd Arzneimittel (DE-588)4003115-9 gnd Antiserum (DE-588)4142741-5 gnd |
| topic_facet | Arzneimittelsicherheit Mikrobielle Kontamination Herstellung Blutserum Tierisches Produkt Arzneimittel Antiserum Aufsatzsammlung Konferenzschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008602860&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000000884 |
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