Research Catalog
Biopharmaceutical process validation
- Title
- Biopharmaceutical process validation / edited by Gail Sofer, Dane W. Zabriskie.
- Publication
- New York : Marcel Dekker, [2000], ©2000.
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| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Request in advance | RS380 .B5526 2000 | Off-site |
Holdings
Details
- Additional Authors
- Description
- xiv, 382 pages : illustrations; 24 cm.
- Series Statement
- Biotechnology and bioprocessing series
- Uniform Title
- Biotechnology and bioprocessing series.
- Subject
- Pharmaceutical biotechnology > Quality control
- Bibliography (note)
- Includes bibliographical references and index.
- Contents
- 1. Regulatory Trends Related to Process Validation / Dane W. Zabriskie -- 2. A Biotech Validation Concept / Norbert Hentschel, Uwe Bucheler and Rolf G. Werner -- 3. Establishing Process Robustness Using Designed Experiments / Brian D. Kelley -- 4. Identification and Establishment of Operating Ranges of Critical Process Variables / Alan R. Gardner and Thomas M. Smith -- 5. Cell Line Characterization / Sandra K. Dusing -- 6. Process Validation and Characterization: Animal Cell Culture Processes / S. R. Adamson, M. Leonard and D. Drapeau / [et al.] -- 7. Recovery Operations / Robert J. Seely, Mark E. Tomusiak and Robert H. Kuhn -- 8. Purification Issues / Marjorie E. Winkler -- 9. Validation of the Purification Process for Viral Clearance Evaluation / Allan J. Darling -- 10. Chromatography Media Lifetime / Gail Sofer -- 11. Validation of Filtration / Gregory M. Morris, John Rozembersky and Larry Schwartz -- 12. Cleaning: Multiuse Facility Issues / David Sherwood --
- 13. Role of Analytical Testing in Biopharmaceutical Analysis / Sudhir Burman and Krish Venkat -- 14. Process Validation in Biopharmaceutical Manufacturing / Sheryl Martin-Moe, William H. Kelsey and Joyce Ellis / [et al.] -- 15. Regulatory Reform of Biotechnology-Derived Products: The Regulatory Impact of Process Changes on Validation / Michael G. Beatrice -- 16. Special Issues for Synthetic Antisense Oligonucleotides / G. Susan Srivatsa, V. Ravikumar and A. N. Scozzari / [et al.] -- 17. Special Issues for DNA Vaccines / Nancy A. Horn, Magda Marquet and Jennifer A. Meek -- 18. Process Development and Process Validation Issues for Plasmid DNA Vaccines / David W. Clark and Richard B. Ciccarelli -- 19. Ex Vivo Autologous Cell Therapies / Susan Schaeffer, Benjamin B. Stone and Jacqueline M. Wolfrum / [et al.].
- ISBN
- 0824702492 (alk. paper)
- LCCN
- 00024958
- OCLC
- 43434664
- ocm43434664
- SCSB-4032718
- Owning Institutions
- Columbia University Libraries