{"product_id":"analysis-of-aggregates-and-particles-in-protein-pharmaceuticals-isbn-9780470497180","title":"Analysis of Aggregates and Particles in Protein Pharmaceuticals","description":"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. \u003cp\u003eContributors ix\u003c\/p\u003e \u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003eGlossary xv\u003c\/p\u003e \u003cp\u003e1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates ofTherapeutic Proteins 1\u003cbr\u003e \u003ci\u003eJohn F. Carpenter, Barry Cherney, and Amy S. Rosenberg\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eI Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles 9\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2 Separation-Based Analytical Methods for Measuring Protein Aggregation 11\u003cbr\u003e \u003ci\u003eJun Liu, Barthélemy Demeule, and Steven J. Shire\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics 37\u003cbr\u003e \u003ci\u003eJohn den Engelsman, Fabian Kebbel, and Patrick Garidel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in ProteinPharmaceuticals 61\u003cbr\u003e \u003ci\u003eTapan K. Das\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Analytical Methods to Measure Subvisible Particulates 85\u003cbr\u003e \u003ci\u003eShawn Cao, Linda Narhi, Yijia Jiang, and Rahul S. Rajan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Detection of Visible Particles in Parenteral Products 117\u003cbr\u003e \u003ci\u003eRonald Smulders, Hans Vos, and Hanns-Christian Mahler\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Characterization of Aggregates and Particles Using Emerging Techniques 133\u003cbr\u003e \u003ci\u003eHui Zhao, Manuel Diez, Atanas Koulov, Mariola Bozova, Markus Bluemel, and Kurt Forrer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eII Methods Used to Characterize Protein Aggregates and Particles 169\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8 Ultraviolet Absorption Spectroscopy 171\u003cbr\u003e \u003ci\u003eReza Esfandiary and Charles Russell Middaugh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles 201\u003cbr\u003e \u003ci\u003eRobert A. Poole, Andrea Hawe, Wim Jiskoot, and Kevin Braeckmans\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Infrared Spectroscopy to Characterize Protein Aggregates 227\u003cbr\u003e \u003ci\u003eMarco van de Weert and Lene Jørgensen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Raman Microscopy for Characterization of Particles 249\u003cbr\u003e \u003ci\u003eStefan Fischer, Oliver Valet, and Markus Lankers\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals 269\u003cbr\u003e \u003ci\u003ePatrick Garidel, Andrea Herre, and Werner Kliche\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIII Integrated Approaches to Protein Aggregation and Particles 303\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization 305\u003cbr\u003e \u003ci\u003eJohn S. Philo\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Protein Purification and Its Relation to Protein Aggregation and Particles 335\u003cbr\u003e \u003ci\u003eRoberto Falkenstein, Stefan Hepbildikler, Wolfgang Kuhne, Thorsten Lemm, Hans Rogl, Eva Rosenberg, Gerhard Winter, Frank Zettl, and Ralf Zippelius\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Formulation Development and Its Relation to Protein Aggregation and Particles 369\u003cbr\u003e \u003ci\u003eMiriam Printz and Wolfgang Friess\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 389\u003c\/p\u003e  \u003cb\u003eHANNS-CHRISTIAN MAHLER\u003c\/b\u003e is Head of Pharmaceutical and Device Development, Pharma Technical Development Biologics Europe at F. Hoffmann-La Roche Ltd. He is also Lecturer at the Institute for Pharmaceutical Technology at the University of Frankfurt\/Main, Germany.  \u003cp\u003e\u003cb\u003eWIM JISKOOT\u003c\/b\u003e is Professor and Head of the Biologics Formulation Group in the Leiden\/Amsterdam Center for Drug Research (LACDR) at Leiden University.\u003c\/p\u003e  \u003cb\u003eEnables researchers to better detect, measure, and characterize aggregates and particles during protein drug development\u003c\/b\u003e  \u003cp\u003eFeaturing contributions from leading pharmaceutical investigators around the world, this text enables researchers to choose the most appropriate analytical methods in order to detect and characterize the full spectrum of protein aggregates and particles that can be present in a protein pharmaceutical. Moreover, the authors provide detailed examples of how these methods can be applied during both process and formulation development, helping researchers better manage the problem of protein instability as they seek to develop protein drugs.\u003c\/p\u003e \u003cp\u003eThe text begins with an introduction to aggregates and particles, focusing on their potential immunogenicity. Next, it covers:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eMethods to detect and measure soluble aggregates based on separation, light scattering, and new technology\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eMethods to detect and measure insoluble aggregates and both sub-visible and visible particles\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eSpectroscopic techniques such as UV\/VIS, fluorescence, infrared and Raman spectroscopy, and microscopy to characterize aggregates and particles, elucidate their structures, and identify proteinaceous and non-proteinaceous particles\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eComparative advantages and disadvantages of the methods for protein aggregate analysis\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eApproaches for managing aggregates and particles found during protein purification and formulation development\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThroughout the text, case studies help researchers deal with the challenges that arise in detecting and analyzing protein aggregates and particles.\u003c\/p\u003e \u003cp\u003eProtein pharmaceuticals are increasingly used to treat life-threatening and chronic diseases, including cancer, viral infections, metabolic disorders, and central nervous system diseases. With \u003ci\u003eAnalysis of Aggregates and Particles in Protein Pharmaceuticals\u003c\/i\u003e as their guide, pharmaceutical researchers now have an important tool in overcoming the challenging problem of aggregates and particles in protein drug development.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988733509861,"sku":"NP9780470497180","price":135.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470497180.jpg?v=1761781377","url":"https:\/\/k12savings.com\/products\/analysis-of-aggregates-and-particles-in-protein-pharmaceuticals-isbn-9780470497180","provider":"K12savings","version":"1.0","type":"link"}