03598nam 2200721 a 450 991082456960332120240514070028.0978661340104597812834010431283401045978111815056611181505629781118150573111815057097811181505421118150546(CKB)2670000000131318(EBL)818481(OCoLC)768082726(SSID)ssj0000570331(PQKBManifestationID)11369625(PQKBTitleCode)TC0000570331(PQKBWorkID)10592371(PQKB)11617810(MiAaPQ)EBC818481(Au-PeEL)EBL818481(CaPaEBR)ebr10521349(CaONFJC)MIL340104(PPN)17900297X(OCoLC)732776465(FINmELB)ELB179199(Perlego)1002278(EXLCZ)99267000000013131820110620d2012 uy 0engur|n|---|||||txtccrAnalysis of aggregates and particles in protein pharmaceuticals /edited by Hanns-Christian Mahler, Wim Jiskoot1st ed.Hoboken, N.J. John Wiley & Sons, Inc.20121 online resource (474 p.)Description based upon print version of record.9780470497180 0470497181 Includes bibliographical references.The 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.This 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.Pharmaceutical chemistryProtein drugsAnalysisPharmaceutical chemistry.Protein drugsAnalysis.615.1/9Mahler Hanns-Christian1682503Jiskoot Wim1682504MiAaPQMiAaPQMiAaPQBOOK9910824569603321Analysis of aggregates and particles in protein pharmaceuticals4052680UNINA