The Resource Validation of biopharmaceutical manufacturing processes, Brian D. Kelley, editor, R. Andrew Ramelmeier, editor, (electronic resource)

Validation of biopharmaceutical manufacturing processes, Brian D. Kelley, editor, R. Andrew Ramelmeier, editor, (electronic resource)

Label
Validation of biopharmaceutical manufacturing processes
Title
Validation of biopharmaceutical manufacturing processes
Statement of responsibility
Brian D. Kelley, editor, R. Andrew Ramelmeier, editor
Contributor
Subject
Genre
Language
eng
Member of
Cataloging source
MUU
Illustrations
illustrations
Index
index present
LC call number
RS380
LC item number
.V34 1998
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorDate
  • 1964-
  • 1997 :
http://library.link/vocab/relatedWorkOrContributorName
  • Kelley, Brian D.
  • Ramelmeier, R. Andrew
  • American Chemical Society
  • American Chemical Society
Series statement
ACS symposium series
Series volume
698
http://library.link/vocab/subjectName
Pharmaceutical biotechnology
Label
Validation of biopharmaceutical manufacturing processes, Brian D. Kelley, editor, R. Andrew Ramelmeier, editor, (electronic resource)
Link
http://libraries.ou.edu/access.aspx?url=http://dx.doi.org/10.1021/bk-1998-0698
Instantiates
Publication
Note
  • Title from PDF title page (ACS publications, viewed Aug 24, 2009)
  • "Developed from a symposium sponsored by the Division of Biochemical Technology, at the 213th National Meeting of the American Chemical Society, San Francisco, California, April 13-17, 1997."
Bibliography note
Includes bibliographical references and indexes
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
Extent
1 online resource (x, 191 p.)
Form of item
electronic
Isbn
9780841216709
Isbn Type
(ebook)
Other physical details
ill.
Specific material designation
remote
System control number
  • 3515761-01okla_normanlaw
  • (SIRSI)3515761
  • (Sirsi) o433115433
  • (OCoLC)433115433
Label
Validation of biopharmaceutical manufacturing processes, Brian D. Kelley, editor, R. Andrew Ramelmeier, editor, (electronic resource)
Link
http://libraries.ou.edu/access.aspx?url=http://dx.doi.org/10.1021/bk-1998-0698
Publication
Note
  • Title from PDF title page (ACS publications, viewed Aug 24, 2009)
  • "Developed from a symposium sponsored by the Division of Biochemical Technology, at the 213th National Meeting of the American Chemical Society, San Francisco, California, April 13-17, 1997."
Bibliography note
Includes bibliographical references and indexes
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
Extent
1 online resource (x, 191 p.)
Form of item
electronic
Isbn
9780841216709
Isbn Type
(ebook)
Other physical details
ill.
Specific material designation
remote
System control number
  • 3515761-01okla_normanlaw
  • (SIRSI)3515761
  • (Sirsi) o433115433
  • (OCoLC)433115433

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