Validation of biopharmaceutical manufacturing processes: developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Washington, DC
American Chemical Soc.
1998
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| Schriftenreihe: | American Chemical Society: ACS symposium series
698 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | IX, 191 S. graph. Darst. |
| ISBN: | 0841235678 |
Internformat
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Datensatz im Suchindex
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| adam_text | ACS S Y M P O S I U M SERIES 698 VALIDATION OF BIOPHARMACEUTICAL
MANUFACTURING PROCESSES S*? ^ BRIAN D. KELLEY, EDITOR GENETICS INSTITUTE
R. ANDREW RAMELMEIER, EDITOR MERCK & CO., INC. DEVELOPED FROM A
SYMPOSIUM SPONSORED BY THE DIVISION OF BIOCHEMICAL TECHNOLOGY, AT THE
213TH NATIONAL MEETING OF THE AMERICAN CHEMICAL SOCIETY, SAN FRANCISCO,
CALIFORNIA, APRIL 13-17, 1997 AMERICAN CHEMICAL SOCIETY, WASHINGTON, DC
CONTENTS PREFACE IX 1. HISTORICAL, CURRENT, AND FUTURE TRENDS FOR
VALIDATING BIOLOGICAL PROCESSES 1 R. ANDREW RAMELMEIER, BRIAN D. KELLEY,
AND CHRISTI VAN HORN 2. PROCESS CHARACTERIZATION STUDIES TO FACILITATE
VALIDATION OF A RECOMBINANT PROTEIN FERMENTATION 12 JINYOU ZHANG, JAY
REDDY, PETER SALMON, BARRY BUCKLAND, AND RANDY GREASHAM 3. VALIDATION OF
CONTINUOUSLY PERFUSED CELL CULTURE PROCESSES FOR PRODUCTION OF
MONOCLONAL ANTIBODIES 28 S. C. WHITAKER, R. FRANCIS, AND R.C. SIEGEL 4.
ESTABLISHMENT OF PROVEN ACCEPTABLE PROCESS CONTROL RANGES FOR PRODUCTION
OF A MONOCLONAL ANTIBODY BY CULTURES OF RECOMBINANT CHO CELLS 44 ROBERT
G. GERBER, PAUL R. MCALLISTER, CAROL A. SMITH, THOMAS M. SMITH, DANE W.
ZABRISKIE, AND ALAN R. GARDNER 5. VALIDATION OF THE RECOMBINANT
COAGULATION FACTOR IX PURIFICATION PROCESS FOR THE REMOVAL OF HOST CELL
DNA 55 M. W. LEONARD, L. SEFTON, R. COSTIGAN, L. SHI, B. HUBBARD, D.
BONAM, B. D. KELLEY, B. FOSTER, AND T. CHARLEBOIS 6. WORST-CASE APPROACH
TO VALIDATION OF OPERATING RANGES 69 ALAN R. GARDNER, THOMAS M. SMITH,
ROBERT G. GERBER, AND DANE W. ZABRISKIE 7. ESTABLISHMENT OF OPERATING
RANGES IN A PURIFICATION PROCESS FOR A MONOCLONAL ANTIBODY 80 THOMAS M.
SMITH, EILEEN WILSON, ROBERT G. SCOTT, JOHN W. MISCZAK, JOHN M. BODEK,
AND DANE W. ZABRISKIE 8. ROBUSTNESS TESTING OF A CHROMATOGRAPHIC
PURIFICATION STEP USED IN RECOMBINANT FACTOR IX MANUFACTURE 93 BRIAN D.
KELLEY, IXI SHI, DUANE BONAM, AND BRIAN HUBBARD VH 9. VIRUS REMOVAL AND
INACTIVATION: A DECADE OF VALIDATION STUDIES: CRITICAL EVALUATION OF THE
DATA SET 114 JOACHIM K. WALTER, FRANZ NOTHELFER, AND WILLIAM WERZ 10.
REUSE VALIDATION OF AN ANION EXCHANGE CHROMATOGRAPHY STEP FOR
PURIFICATION OF CLINICAL-GRADE CILIARY NEUROTROPHIC FACTOR 125 SOMESH
NIGAM, GARY RUEZINSKY, AND JAMES DUGGER 11. START-UP AND VALIDATION OF
STERILE FORMULATION AND FILLING PROCESSES FOR THE MANUFACTURE OF
PARENTERAL ALUMINUM HYDROXIDE-BASED VACCINES 144 R. A. RAMELMEIER, P. M.
MCHUGH, M. S. RIENSTRA, C. J. ORELLA, W. L. STOBART, M. W. HENLEY, AND
R. D. SITRIN 12. CHANGES IN BIOLOGIES REGULATIONS: IMPACT ON THE
DEVELOPMENT AND VALIDATION OF THE MANUFACTURING PROCESSES FOR
WELL-CHARACTERIZED PRODUCTS 170 KIMBERLEE K. WALLACE AND ANTONIO R.
MOREIRA AUTHOR INDEX 183 SUBJECT INDEX 185 VIII
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| illustrated | Illustrated |
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| isbn | 0841235678 |
| language | English |
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| spelling | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 Brian D. Kelley ..., ed. Washington, DC American Chemical Soc. 1998 IX, 191 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier American Chemical Society: ACS symposium series 698 Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf (DE-588)1071861417 Konferenzschrift 1997 San Francisco Calif. gnd-content Pharmazeutische Technologie (DE-588)4045699-7 s Biotechnologie (DE-588)4069491-4 s DE-604 Kelley, Brian D. Sonstige oth American Chemical Society: ACS symposium series 698 (DE-604)BV000003091 698 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008491466&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 American Chemical Society: ACS symposium series Pharmazeutische Technologie (DE-588)4045699-7 gnd Biotechnologie (DE-588)4069491-4 gnd |
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| title | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 |
| title_auth | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 |
| title_exact_search | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 |
| title_full | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 Brian D. Kelley ..., ed. |
| title_fullStr | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 Brian D. Kelley ..., ed. |
| title_full_unstemmed | Validation of biopharmaceutical manufacturing processes developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 Brian D. Kelley ..., ed. |
| title_short | Validation of biopharmaceutical manufacturing processes |
| title_sort | validation of biopharmaceutical manufacturing processes developed from a symposium at the 213th national meeting of the american chemical society san francisco calif april 13 17 1997 |
| title_sub | developed from a symposium ... at the 213th national meeting of the American Chemical Society, San Francisco, Calif., April 13 - 17, 1997 |
| topic | Pharmazeutische Technologie (DE-588)4045699-7 gnd Biotechnologie (DE-588)4069491-4 gnd |
| topic_facet | Pharmazeutische Technologie Biotechnologie Konferenzschrift 1997 San Francisco Calif. |
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