Validation of Biopharmaceutical Manufacturing Processes

Content: Historical, current, and future trends for validating biological processes / R. Andrew Ramelmeier, Brian D. Kelley, and Christi Van Horn -- Process characterization studies to facilitate validation of a recombinant protein fermentation / Jinyou Zhang, Jay Reddy, Peter Salmon, Barry Buckland, and Randy Greasham -- Validation of continuously perfused cell culture processes for production of monoclonal antibodies / S.C. Whitaker, R. Francis, and R.C. Siegel -- Establishment of proven acceptable process control ranges for production of a monoclonal antibody by cultures of recombinant CHO cells / Robert G. Gerber, Paul R. McAllister, Carol A. Smith, Thomas M. Smith, Dane W. Zabriskie, and Alan R. Gardner -- Validation of the recombinant coagulation Factor IX purification process for the removal of host cell DNA / M.W. Leonard, L. Sefton, R. Costigan, L. Shi, B. Hubbard, D. Bonam, B.D. Kelley, B. Foster, and T. Charlebois -- Worst-case approach to validation of operating ranges / Alan R. Gardner, Thomas M. Smith, Robert G. Gerber, and Dane W. Zabriskie -- Establishment of operating ranges in a purification process for a monoclonal antibody / Thomas M. Smith, Eileen Wilson, Robert G. Scott, John W. Misczak, John M. Bodek, and Dane W. Zabriskie -- Robustness testing of a chromatographic purification step used in recombinant Factor IX manufacture / Brian D. Kelley, Lei Shi, Duane Bonam, and Brian Hubbard -- Virus removal and inactivation : a decade of validation studies : critical evaluation of the data set / Joachim K. Walter, Franz Nothelfer, and William Werz -- Reuse validation of an anion exchange chromatography step for purification of clinical-grade ciliary neurotrophic factor / Somesh Nigam, Gary Ruezinsky, and James Dugger -- Start-up and validation of sterile formulation and filling processes for the manufacture of parenteral aluminum hydroxide-based vaccines / R.A. Ramelmeier, P.M. McHugh, M.S. Rienstra, C.J. Orella, W.L. Stobart, M.W. Henley, and R.D. Sitrin -- Changes in biologics regulations : impact on the development and validation of the manufacturing processes for well-characterized products / Kimberlee K. Wallace and Antonio R. Moreira.