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100   $a20110620d2012      uy         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 00$aAnalysis of aggregates and particles in protein pharmaceuticals /$fedited by Hanns-Christian Mahler, Wim Jiskoot
205   $a1st ed.
210   $aHoboken, N.J. $cJohn Wiley & Sons, Inc.$d2012
215   $a1 online resource (474 p.)
300   $aDescription based upon print version of record.
311 08$a9780470497180 
311 08$a0470497181 
320   $aIncludes bibliographical references.
327   $aThe critical need for robust assays for quantitation and characterization of aggregates of therapeutic proteins -- Separation based analytical methods for measuring protein aggregation -- Laser light scattering-based techniques used for the characterization of protein therapeutics -- Online detection methods and emerging techniques for soluble aggregates in protein pharmaceuticals -- Analytical methods to measure sub-visible particulates -- Detection of visible particles in parenteral products -- Characterization of aggregates and particles using emerging techniques -- Ultraviolet absorption spectroscopy -- Fluorescence spectroscopy to characterize protein aggregates and particles -- Infrared spectroscopy to characterize protein aggregates -- Raman microscopy for characterization of particles -- Microscopic methods for particle characterization in protein pharmaceuticals -- Comparison of methods for soluble aggregate detection and size characterization -- Protein purification and its relation to protein aggregation and particles -- Formulation development and its relation to protein aggregation and particles.
330   $aThis book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
606   $aPharmaceutical chemistry
606   $aProtein drugs$xAnalysis
615  0$aPharmaceutical chemistry.
615  0$aProtein drugs$xAnalysis.
676   $a615.1/9
701   $aMahler$b Hanns-Christian$01682503
701   $aJiskoot$b Wim$01682504
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910824569603321
996   $aAnalysis of aggregates and particles in protein pharmaceuticals$94052680
997   $aUNINA