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- 2012001495 contributor B12428525.
- 2012001495 created "2012.".
- 2012001495 date "2012".
- 2012001495 date "2012.".
- 2012001495 dateCopyrighted "2012.".
- 2012001495 description "Guidelines to process validation / Gail Sofer -- Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman -- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- Process characterization / James E. Seely -- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer -- Validation of a filtration step / Jennifer Campbell -- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- Facility design issues : a regulatory perspective / Sue Vargo -- Validation of computerized systems / Monica J. Cahilly -- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- Risk management & validation / James Agalloco -- Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz -- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- Process validation of a multivalent bacterial vaccine : a novel -- Matrix approach / Narahari S. Pujar ... [et al.] -- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes -- Viral clearance validation : a case study / Michael Rubino ... [et al.].".
- 2012001495 description "Includes bibliographical references and index.".
- 2012001495 extent "p. ;".
- 2012001495 identifier "9781439850930 (hardcover : alk. paper)".
- 2012001495 isPartOf "Biotechnology and bioprocessing series ; 35".
- 2012001495 isPartOf "Biotechnology and bioprocessing series ; 35.".
- 2012001495 issued "2012".
- 2012001495 issued "2012.".
- 2012001495 language "eng".
- 2012001495 publisher "Boca Raton : Taylor & Francis/CRC Press,".
- 2012001495 subject "615.1/9 23".
- 2012001495 subject "Biopharmaceutics.".
- 2012001495 subject "Biotechnology.".
- 2012001495 subject "Drug Approval.".
- 2012001495 subject "QV 38".
- 2012001495 subject "Quality Control.".
- 2012001495 tableOfContents "Guidelines to process validation / Gail Sofer -- Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman -- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- Process characterization / James E. Seely -- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer -- Validation of a filtration step / Jennifer Campbell -- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- Facility design issues : a regulatory perspective / Sue Vargo -- Validation of computerized systems / Monica J. Cahilly -- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- Risk management & validation / James Agalloco -- Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz -- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- Process validation of a multivalent bacterial vaccine : a novel -- Matrix approach / Narahari S. Pujar ... [et al.] -- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes -- Viral clearance validation : a case study / Michael Rubino ... [et al.].".
- 2012001495 title "Process validation in manufacturing of biopharmaceuticals / editors, Anurag Rathore, Gail Sofer.".
- 2012001495 type "text".