Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies / edited by Anurag Singh Rathore, Gail Sofer.

Contributor(s): Rathore, Anurag S. (Anurag Singh), 1973- | Sofer, G. K Material type: Text

TextLanguage: English Series: Biotechnology and bioprocessing series ; 29Publication details: Boca Raton : Taylor & Francis, 2005. Description: xxi, 578 p. : ill. ; 23 cmISBN: 1574445162 (alk. paper); 9781574445169Subject(s): Pharmaceutical biotechnology -- Quality control | Biotechnological process monitoringDDC classification: 615.19 LOC classification: RS380 | .P76 2005Online resources: Publisher description | WorldCat details | E-book fulltext

Contents:

1. Guidelines to process validation -- 2. Applications of failure modes and effects analysis to biotechnology manufacturing processes -- 4. Scale-down models for purification processes: approaches and applications -- 5. Adventitious agents: concerns and testing for Biopharmaceuticals -- 6. Life span studies for Chromatography and filtration media -- 7. Validation of a filtration step -- 8. Analytical test methods for biological and biotechnological products -- 9. Facility design issues -- a regulatory perspective -- 10. Validation of computerized systems -- 11. Process optimization and characterization studies for putification of an E. coli- expressed protein product -- 12. Validation of the Zevalin® purification process -- 13. Process validation of a multivalent bacterial vaccine -- 14. Viral clearance validation -- Index. TOC

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Holdings
Item type	Current library	Collection	Call number	Copy number	Status	Barcode
E-Book	Dr. S. R. Lasker Library, EWU E-book	Non-fiction	615.19 PRO 2005 (Browse shelf(Opens below))		Not for loan
Text	Dr. S. R. Lasker Library, EWU Reserve Section	Non-fiction	615.19 PRO 2005 (Browse shelf(Opens below))	C-1	Not For Loan	18093
Text	Dr. S. R. Lasker Library, EWU Circulation Section	Non-fiction	615.19 PRO 2005 (Browse shelf(Opens below))	C-2	Available	18094
Text	Dr. S. R. Lasker Library, EWU Circulation Section	Non-fiction	615.19 PRO 2005 (Browse shelf(Opens below))	C-3	Available	18095

Total holds: 0

Includes bibliographical references and index.

1. Guidelines to process validation --
2. Applications of failure modes and effects analysis to biotechnology manufacturing processes --
4. Scale-down models for purification processes: approaches and applications --
5. Adventitious agents: concerns and testing for Biopharmaceuticals --
6. Life span studies for Chromatography and filtration media --
7. Validation of a filtration step --
8. Analytical test methods for biological and biotechnological products --
9. Facility design issues --
a regulatory perspective --
10. Validation of computerized systems --
11. Process optimization and characterization studies for putification of an E. coli- expressed protein product --
12. Validation of the Zevalin® purification process --
13. Process validation of a multivalent bacterial vaccine --
14. Viral clearance validation --
Index. TOC

Pharmacy

Shamima Yeasmin

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