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Process validation in manufacturing ...

Rathore, Anurag S. (1973-)

Process validation in manufacturing of biopharmaceuticals /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615.1/9
書名/作者:	Process validation in manufacturing of biopharmaceuticals // edited by Anurag S. Rathore, Gail Sofer.
其他作者:	Rathore, Anurag S.
出版者:	Boca Raton : : CRC Press/Taylor & Francis,, c2012.
面頁冊數:	xvii, 513 p. : : ill. ;; 25 cm.
標題:	Pharmaceutical biotechnology - Quality control.
標題:	Biotechnological process monitoring.
標題:	Biopharmaceutics.
ISBN:	9781439850930 (hbk.) :
ISBN:	1439850933 (hbk.)
書目註:	Includes bibliographical references and index.
內容註:	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.].

Process validation in manufacturing of biopharmaceuticals /
Process validation in manufacturing of biopharmaceuticals /edited by Anurag S. Rathore, Gail Sofer. - 3rd ed. - Boca Raton :CRC Press/Taylor & Francis,c2012. - xvii, 513 p. :ill. ;25 cm. - Biotechnology and bioprocessing series ;35. - Biotechnology and bioprocessing series ;32..

Includes bibliographical references and index.

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.].

ISBN: 9781439850930 (hbk.) :NTD 5,130

LCCN: 2012001495Subjects--Topical Terms:

502696
Pharmaceutical biotechnology
--Quality control.

Dewey Class. No.: 615.1/9

Process validation in manufacturing of biopharmaceuticals /
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