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 ... [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 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 ... [et al.] -- 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 ... [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 ... [et al.].