Isbn: 9780470497180 - analysis of aggregates and particles in protein pharmaceuticals (17 risultati)

Hardcover. Condizione: Good. 1st Edition. Hardcover, xvi + 443pp + 12 pages of glossy plates, NOT ex-library. Neatly removed title-page; front blank endpapers stuck to the front board. Pages are very good: clean and bright throughout, with unmarked text, free of inscriptions and stamps, firmly bound. Cosmetic damage on the spine (not affecting the book's binding) - a long diagonal incision and faint glue marks. Issued without a dust jacket. -- This work provides a comprehensive guide to the analytical strategies for addressing the critical challenge of aggregation in biopharmaceuticals, a phenomenon impacting product quality, safety, and efficacy. Systematically organized to address the full size spectrum - from soluble species to subvisible and visible matter - the book details an array of methods for detection, quantification, and sizing, including separation-based approaches and laser light scattering. It then delves into deeper characterization, employing powerful spectroscopic and microscopic techniques such as ultraviolet absorption, fluorescence, infrared, and Raman to elucidate structural and compositional attributes, which is crucial for differentiating proteinaceous from nonproteinaceous contaminants. Finally, the text moves beyond pure measurement to practical application, offering a direct comparison of methodologies to aid in assay selection and demonstrating how this analytical toolkit is applied to mitigate challenges during key manufacturing stages like purification and formulation development, making it an essential resource for scientists and regulators involved in biotherapeutic development. -- Contents: Glossary; 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins / John F. Carpenter; I Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles 2 Separation-Based Analytical Methods for Measuring Protein Aggregation / Jun Liu; 3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics / John den Engelsman; 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals / Tapan K. Das; 5 Analytical Methods to Measure Subvisible Particulates / Shawn Cao; 6 Detection of Visible Particles in Parenteral Products / Ronald Smulders; 7 Characterization of Aggregates and Particles Using Emerging Techniques / Hui Zhao; II Methods Used to Characterize Protein Aggregates and Particles 8 Ultraviolet Absorption Spectroscopy / Reza Esfandiary & Charles Russell Middaugh; 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles / Robert A. Poole; 10 Infrared Spectroscopy to Characterize Protein Aggregates / Marco van de Weert & Lene Jorgensen; 11 Raman Microscopy for Characterization of Particles / Stefan Fischer; 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals / Patrick Garidel; III Integrated Approaches to Protein Aggregation and Particles 13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization / John S. Philo; 14 Protein Purification and Its Relation to Protein Aggregation and Particles / Roberto Falkenstein; 15 Formulation Development and Its Relation to Protein Aggregation and Particles / Miriam Printz & Wolfgang Friess; Index.…

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Hardback. Condizione: New. 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.…

Buch. Condizione: Neu. Neuware - 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. Enables researchers to better detect, measure, and characterize aggregates and particles during protein drug developmentFeaturing 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.The text begins with an introduction to aggregates and particles, focusing on their potential immunogenicity. Next, it covers:Methods to detect and measure soluble aggregates based on separation, light scattering, and new technologyMethods to detect and measure insoluble aggregates and both sub-visible and visible particlesSpectroscopic 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 particlesComparative advantages and disadvantages of the methods for protein aggregate analysisApproaches for managing aggregates and particles found during protein purification and formulation developmentThroughout the text, case studies help researchers deal with the challenges that arise in detecting and analyzing protein aggregates and particles.Protein pharmaceuticals are increasingly used to treat life-threatening and chronic diseases, including cancer, viral infections, metabolic disorders, and central nervous system diseases. With Analysis of Aggregates and Particles in Protein Pharmaceuticals as their guide, pharmaceutical researchers now have an important tool in overcoming the challenging problem of aggregates and particles in protein drug development.…

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Buch. Condizione: Neu. Analysis of Aggregates and Particles in Protein Pharmaceuticals | H-C Mahler | Buch | Contributors ixPreface xiiiGlossary xv1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins 1John F. Carpenter | Englisch | 2012 | John Wiley & Sons Inc | EAN 9780470497180 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu.…

Hardback. Condizione: New. 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.…

Gebundene Ausgabe. Condizione: Wie neu. 464 Seiten; Buchdeckel minimal berieben/bestossen. Innenteil tadellos - u n g e l e s e n - keine Risse, Knicke, Anmerkungen. ! Altersbedingt minimal nachgedunkelt! KEIN Mängelexemplar! Versand aus München V1262 Sprache: Deutsch Gewicht in Gramm: 798.