An edition of Process validation in manufacturing of biopharmaceuticals (2012)

Process validation in manufacturing of biopharmaceuticals

3rd ed.

by and

Process validation in manufacturing of biopha ...
Anurag S. Rathore, G. K. Sofer ...
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Last edited by LC Bot
March 15, 2012 | History
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An edition of Process validation in manufacturing of biopharmaceuticals (2012)

Process validation in manufacturing of biopharmaceuticals

3rd ed.

by and

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Publish Date
Publisher
Taylor & Francis/CRC Press
Language
English

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Subjects

Biopharmaceutics, Quality Control, Drug Approval, Biotechnology

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Edition Availability
Cover of: Process validation in manufacturing of biopharmaceuticals
Process validation in manufacturing of biopharmaceuticals
2012, Taylor & Francis/CRC Press
in English - 3rd ed.
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Book Details

Table of 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 ... [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.].

Edition Notes

Includes bibliographical references and index.

Published in
Boca Raton
Series
Biotechnology and bioprocessing series -- 33, Biotechnology and bioprocessing series -- 33.

Classifications

Dewey Decimal Class
615.1/9

The Physical Object

Pagination
p. ;

ID Numbers

Open Library
OL25237253M
ISBN 13
9781439850930
LCCN
2012001495

Source records

Library of Congress MARC record
Library of Congress MARC record
Library of Congress MARC record

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