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Process validation in manufacturing of biopharmaceuticals

Author: Anurag S Rathore; G K Sofer
Publisher: Boca Raton : Taylor & Francis/CRC Press, 2012.
Series: Biotechnology and bioprocessing series, 35.
Edition/Format:   Print book : English : 3rd edView all editions and formats
Database:WorldCat
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Document Type: Book
All Authors / Contributors: Anurag S Rathore; G K Sofer
ISBN: 9781439850930 1439850933 9781439850947 1439850941
OCLC Number: 762991396
Description: xvii, 513 pages : illustrations ; 25 cm.
Contents: 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 [and others] --
Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims [and others] --
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 [and others] --
Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes --
Viral clearance validation : a case study / Michael Rubino [and others].
Series Title: Biotechnology and bioprocessing series, 35.
Responsibility: edited by, Anurag Rathore, Gail Sofer.
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