Process validation in manufacturing of biopharmaceuticals
By: editors, Anurag Rathore, Gail Sofer
Edition: 3rd ed.
Series: Biotechnology and bioprocessing series -- 33; Biotechnology and bioprocessing series -- 33.
Publisher: Taylor & Francis/CRC Press; CRC Press
Published: 2012
Place of publication: Boca Raton
Language: eng
Number of pages: 532
ISBN-13: 9781439850930
Subjects: Biopharmaceutics; Quality Control; Drug Approval; Biotechnology
Notes: Includes bibliographical references and index.
Table of contents: title: Guidelines to process validation / Gail Sofer; title: Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman; title: Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury; title: Process characterization / James E. Seely; title: Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.]; title: Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.]; title: Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer; title: Validation of a filtration step / Jennifer Campbell; title: Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire; title: Facility design issues : a regulatory perspective / Sue Vargo; title: Validation of computerized systems / Monica J. Cahilly; title: Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer; title: Risk management & validation / James Agalloco; title: Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz; title: Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar; title: Process validation of a multivalent bacterial vaccine : a novel; title: Matrix approach / Narahari S. Pujar ... [et al.]; title: Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes; title: Viral clearance validation : a case study / Michael Rubino ... [et al.].