Process validation for manufacturing of biologics and biotechnology products: Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables
Gespeichert in:
| Weitere beteiligte Personen: | |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Basel [u.a.]
Karger
2003
|
| Schriftenreihe: | Developments in biologicals
113 |
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=019942099&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | X, 129 S. graph. Darst. |
| ISBN: | 3805575769 |
Internformat
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Datensatz im Suchindex
| _version_ | 1819257294847737856 |
|---|---|
| adam_text | Contents
Session I
Expectations for Process Validation 1
Moderators: G. Murano (Genentech, USA)
B. Hughes (Wyeth Biopharma, USA)
Canadian Perspectives on Expectations for Process Validation 3
A. Ridgway
Expectations for Process Validation: Industry Perspectives 9
R. Francis
Session II
Strategies: Evolution of Validation Through the Product Ufe Cycle 15
Moderators: G. Roessling (Schering, Germany)
1. Purves (European Medicines Evaluation Agency, UK)
Statistical Tools for Setting In-Process Acceptance Criteria 17
R.J. Seely, L. Munyakazi, J. Haury
Experience with Validation of Clinical Trial Materials: An Inspector s Viewpoint 27
L Wolfe
Session III
Upstream Processes 35
Moderators: A. Lubiniecki (GlaxoSmithKline, USA)
C. Joneckis (CBER/FDA, USA)
Validation of Fermentation Processes 37
A.S. Lubiniecki, A.R. Gardner, T.M. Smith, W.K. Wang, P.R. McAllister, M.M. Federici
Concurrent Breakout Sessions I
Strategies: Evolution of Validation Through the Product Ufe Cycle 45
Moderator: B. Hughes (Wyeth Biopharma, USA)
Site Transfer and Process Validation in Case of Herceptin API 47
W.Kuhne
IX
Post-Approval Changes: Case Study 51
Moderators: M. Malarkey (CBER, FDA, USA)
B. Casey (ThromboGenics, Ireland)
Detection and Consequences of Recombinant Protein Isoforms: Implications for Biological Potency 53
M.M. Federici, K. Venkat, N. Bam, K. Patel, PR. Dal Monte, B. Fernie, P. Hensley, S. Carr,
J. Baldoni, A. Truneh, J. Erickson
Session TV
Physical Methods of Separation 59
Moderators: N. Hentschel (Boehringer Ingelheim Pharma, Germany)
A.Ridgway (Bureau of Biologies, Health Canada)
Current Issues in Validation of Chromatography 61
G. Sofer
Validation of Sterilizing Grade Filtration 65
M.W.Jomitz,T.H. Meltzer
Session V
Viral Clearance 71
Moderators: G. Vicari(Italy)
E. Bucci (Kedrion, Italy)
Viruses and Assuring Viral Safety 73
J.S. Robertson
Concurrent Breakout Sessions II
Viral Clearance and Inactivation 79
Moderator: H. Willkommen (Paul-Ehrlich-Institut, Germany)
Manufacturing Process for Antithrombin III Concentrate: Viral Validation Studies and Effects of
Column Re-Use on Viral Safety 81
A. Falbo
An Overview of Quantitative PCR Assays for Biologicals: Quality and Safety Evaluation 89
Y. Xu, K. Brorson
Re-Processing 99
Moderators: V. Anicetti (Genentech, USA)
R. Franceschini (Kedrion, Italy)
Re-Processing Strategies for Biologicals API Manufacturing Processes 101
U. Opitz
Re-Processing of Biological Products: Regulatory Considerations from the CBER Perspective 105
E. Shacter
Summary of Concurrent Sessions 109
Closing Remarks 117
|
| any_adam_object | 1 |
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| discipline | Chemie / Pharmazie |
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| genre | (DE-588)1071861417 Konferenzschrift 2001 Berlin gnd-content |
| genre_facet | Konferenzschrift 2001 Berlin |
| id | DE-604.BV025311089 |
| illustrated | Illustrated |
| indexdate | 2024-12-20T14:25:31Z |
| institution | BVB |
| isbn | 3805575769 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-019942099 |
| oclc_num | 237801885 |
| open_access_boolean | |
| owner | DE-11 |
| owner_facet | DE-11 |
| physical | X, 129 S. graph. Darst. |
| publishDate | 2003 |
| publishDateSearch | 2003 |
| publishDateSort | 2003 |
| publisher | Karger |
| record_format | marc |
| series | Developments in biologicals |
| series2 | Developments in biologicals |
| spellingShingle | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables Developments in biologicals Produktsicherheit (DE-588)4246587-4 gnd Bioverfahrenstechnik (DE-588)4307166-1 gnd Biologisches Material (DE-588)4145633-6 gnd Qualität (DE-588)4047966-3 gnd Validierung (DE-588)4187357-9 gnd |
| subject_GND | (DE-588)4246587-4 (DE-588)4307166-1 (DE-588)4145633-6 (DE-588)4047966-3 (DE-588)4187357-9 (DE-588)1071861417 |
| title | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables |
| title_auth | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables |
| title_exact_search | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables |
| title_full | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables eds. Fred Brown ... |
| title_fullStr | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables eds. Fred Brown ... |
| title_full_unstemmed | Process validation for manufacturing of biologics and biotechnology products Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables eds. Fred Brown ... |
| title_short | Process validation for manufacturing of biologics and biotechnology products |
| title_sort | process validation for manufacturing of biologics and biotechnology products berlin hilton hotel berlin germany 6 7 september 2001 20 tables |
| title_sub | Berlin Hilton Hotel, Berlin, Germany, 6 - 7 september, 2001 ; 20 tables |
| topic | Produktsicherheit (DE-588)4246587-4 gnd Bioverfahrenstechnik (DE-588)4307166-1 gnd Biologisches Material (DE-588)4145633-6 gnd Qualität (DE-588)4047966-3 gnd Validierung (DE-588)4187357-9 gnd |
| topic_facet | Produktsicherheit Bioverfahrenstechnik Biologisches Material Qualität Validierung Konferenzschrift 2001 Berlin |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=019942099&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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