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008			120427s2012 fluad sb 001 0 eng d
020			_a9781439850947 (ebook : PDF)
040			_aFlBoTFG _cFlBoTFG
090			_aRM301.4 _b.P76 2012
092			_a615.19 _bP963
245	0	0	_aProcess validation in manufacturing of biopharmaceuticals _h[electronic resource] / _cedited by Anurag S. Rathore, Gail Sofer.
250			_a3rd ed.
260			_aBoca Raton : _bCRC Press, _c2012.
300			_axvii, 513 p. : _bill.
490	1		_aBiotechnology and bioprocessing series ; _v35
504			_aIncludes bibliographical references and index.
505	0		_ach. 1. Guidelines to process validation / Gail Sofer -- ch. 2. Commentary on the US Food and Drug Administration's 2011 "Guidance for industry, process validation general principles and practices" / Hal Baseman -- ch. 3. Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- ch. 4. Process characterization / James E. Seely -- ch. 5. Scaled-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- ch. 6. Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- ch. 7. Lifespan studies for chromatography and filtration media / Anurag S. Rathore and Gail Sofer -- ch. 8. Validation of a filtration step / Jennifer Campbell -- ch. 9. Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- ch. 10. Facility design issues : a regulatory perspective / Susan Vargo and Nancy Kavanaugh -- ch. 11. Validation of computerized systems / Monica J. Cahilly -- ch. 12. Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- ch. 13. Risk management and validation / James Agalloco -- ch. 14. Process validation in membrane chromatography / Suma Ray and Miyako Hirai -- ch. 15. Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- ch. 16. Process validation of a multivalent bacterial vaccine : a novel matrix approach / Narahari S. Pujar ... [et al.] -- ch. 17. Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and J�org Th�ommes -- ch. 18. Viral clearance validation : a case study / Michael Rubino ... [et al
530			_aAlso available in print editi
538			_aMode of access: World Wide W
650			_aBiopharmaceuti
650			_aQuality contr
655			_aElectronic books. _2l
700			_aRathore, Anurag S. _q(Anurag Singh), _d19
700			_aSofer, G.
776			_z9781439850930 (hardcover : alk. pap
830			_aBiotechnology and bioprocessing series ; _v
856			_uhttp://marc.crcnetbase.com/isbn/9781439850947 _qapplication/PDF _zDistributed by publisher. Purchase or institutional license may be required for acce
999			_c15016 _d15016