Biopharmaceutical process validation. (©2000)

• Record Type: Book
• Further Information: Note: Edited by Gail Sofer, Dane W. Zabriskie.
• Other Names: Sofer, Gail; Zabriskie, Dane W, 1950-
• Contents: 1. Regulatory trends related to process validation / Dane W. Zabriskie -- 2. A biotech validation concept / Norbert Hentschel, Uwe B¿cheler, 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].
• Publisher Details: New York : Marcel Dekker
• Publication Date: 2000
• Copyright Date: 2000
• Extent: 1 online resource (xiv, 382 pages), illustrations
• Subjects: 615/.19; Pharmaceutical biotechnology -- Quality control; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Pharmaceutical biotechnology -- Quality control; Biopharmaceutics; Biotechnology; Quality Control; Electronic books
• Languages: English
• ISBNs: 0585362955; 9780585362953; 9781420001655; 1420001655
• Related ISBNs: 0824702492; 9780824702496
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.