Validation of biopharmaceutical manufacturing processes /

Bibliographic Details
Corporate Authors:	American Chemical Society. Division of Biochemical Technology, American Chemical Society. Meeting
Other Authors:	Kelley, Brian D., 1964-, Ramelmeier, R. Andrew
Format:	eBook
Language:	English
Language Notes:	English.
Published:	Washington, D.C. : [New York] : American Chemical Society ; Distributed by Oxford University Press, ©1998.
Series:	ACS symposium series ; 698.
Subjects:	Pharmaceutical biotechnology > Congresses. Drugs. Biotechnology. Bioengineering. Recombinant proteins. Fermentation. Monoclonal antibodies. Economics. Vaccines. Research. Biologicals. Technology, Pharmaceutical > methods Biotechnology > methods Pharmaceutical Preparations Biotechnology Biotechnology > instrumentation Recombinant Proteins Fermentation Antibodies, Monoclonal DNA > isolation & purification Economics Antibodies, Monoclonal > isolation & purification Recombinant Proteins > isolation & purification Virus Inactivation Cytokines > isolation & purification Vaccines Legislation as Topic Biological Products Research United States Biotechnologie pharmaceutique > Congrès. Médicaments. Biotechnologie. Protéines recombinantes. Anticorps monoclonaux. Économie politique. Vaccins. Recherche. Médicaments biologiques. bioengineering. economics. research (function) MEDICAL > Pharmacology. Recombinant proteins Monoclonal antibodies Drugs Bioengineering Pharmaceutical biotechnology Industrie pharmaceutique > Biotechnologie > Congrès. Biopharmacie. Industrie pharmaceutique > Qualité > Contrôle. Médicaments > Biotechnologie. biopharmaceutical manufacturing processes validation chemical biochemical technology ACS Electronic books. Congress proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès.
Online Access:	Connect to the full text of this electronic book

Table of Contents:

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.