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EBOOK
Title Biopharmaceutical process validation / edited by Gail Sofer, Dane W. Zabriskie.
Imprint New York : Marcel Dekker, 2000.

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Series Biotechnology and bioprocessing series
Biotechnology and bioprocessing series.
Subject Pharmaceutical biotechnology -- Quality control.
Biopharmaceutics.
Biotechnology.
Quality Control.
Alt Name Sofer, Gail.
Zabriskie, Dane W., 1950-
Description 1 online resource (xiv, 382 pages) : illustrations
Bibliography Note Includes bibliographical references and index.
Note Print version record.
Contents 1. Regulatory trends related to process validation / Dane W. Zabriskie -- 2. A biotech validation concept / Norbert Hentschel, Uwe Bcheler, 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 [and others] -- 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 Safer -- 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 [and others] -- 15. Regulatory reform for biotechnology-derived products : the regulatory impact of process changes on validation / Michael G. Beatrice -- 16. Special issues for synthetic antisense oligonucleotides / G. Susan Srivatsa [and others] -- 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 [and others].
ISBN 0585362955 (electronic bk.)
9780585362953 (electronic bk.)
9781420001655 (electronic bk.)
1420001655 (electronic bk.)
0824702492 (alk. paper)
9780824702496 (alk. paper)
OCLC # 47010925
Additional Format Print version: Biopharmaceutical process validation. New York : Marcel Dekker, 2000 0824702492 (DLC) 00024958 (OCoLC)43434664
Table of Contents
 Series Introduction 
 Preface 
 Contributors 
1Regulatory Trends Related to Process Validation / Dane W. Zabriskie1
2A Biotech Validation Concept / Norbert Hentschel, Uwe Bucheler, Rolf G. Werner17
3Establishing Process Robustness Using Designed Experiments / Brian D. Kelley29
4Identification and Establishment of Operating Ranges of Critical Process Variables / Alan R. Gardner, Thomas M. Smith61
5Cell Line Characterization / Sandra K. Dusing77
6Process Validation and Characterization: Animal Cell Culture Processes [et al.] / S. R. Adamson, M. Leonard, D. Drapeau101
7Recovery Operations / Robert J. Seely, Mark E. Tomusiak, Robert H. Kuhn129
8Purification Issues / Marjorie E. Winkler143
9Validation of the Purification Process for Viral Clearance Evaluation / Allan J. Darling157
10Chromatography Media Lifetime / Gail Sofer197
11Validation of Filtration / Gregory M. Morris, John Rozembersky, Larry Schwartz213
12Cleaning: Multiuse Facility Issues / David Sherwood235
13Role of Analytical Testing in Biopharmaceutical Analysis / Sudhir Burman, Krish Venkat251
14Process Validation in Biopharmaceutical Manufacturing [et al.] / Sheryl Martin-Moe, William H. Kelsey, Joyce Ellis287
15Regulatory Reform of Biotechnology-Derived Products: The Regulatory Impact of Process Changes on Validation / Michael G. Beatrice299
16Special Issues for Synthetic Antisense Oligonucleotides [et al.] / G. Susan Srivatsa, V. Ravikumar, A. N. Scozzari309
17Special Issues for DNA Vaccines / Nancy A. Horn, Magda Marquet, Jennifer A. Meek329
18Process Development and Process Validation Issues for Plasmid DNA Vaccines / David W. Clark, Richard B. Ciccarelli347
19Ex Vivo Autologous Cell Therapies [et al.] / Susan Schaeffer, Benjamin B. Stone, Jacqueline M. Wolfrum361
 Index373


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