000			02846cam a22003618a 4500
999			_c7389 _d7389
001			17191395
005			20190509111644.0
008			120221s2012 flu b 001 0 eng
010			_a 2012001495
020			_a9781439850930 (hardcover : alk. paper)
040			_aDNLM/DLC _cDLC _dDLC _erda
082	0	0	_a615.19 _223 _bP
245	0	0	_aProcess validation in manufacturing of biopharmaceuticals / _ceditors, Anurag Rathore, Gail Sofer.
250			_a3rd ed.
260			_aBoca Raton : _bTaylor & Francis/CRC Press, _c2012.
300			_ap. ; _ccm.
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
490	1		_aBiotechnology and bioprocessing series ; _v35
504			_aIncludes bibliographical references and index.
505	0		_aGuidelines 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.].
650	1	2	_aBiopharmaceutics.
650	2	2	_aBiotechnology.
650	2	2	_aDrug Approval.
650	2	2	_aQuality Control.
700	1		_aRathore, Anurag S. _q(Anurag Singh), _d1973-
700	1		_aSofer, G. K.
830		0	_aBiotechnology and bioprocessing series ; _v35.
856			_3Abstract _uhttp://repository.fue.edu.eg/xmlui/handle/123456789/1677
942			_cBK _2ddc