Analysis of Aggregates and Particles in Protein Pharmaceuticals

Langue : anglais

Edité par Wiley, 2012

0470497181 / 9780470497180

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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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Titre
Analysis of Aggregates and Particles in Protein Pharmaceuticals
Auteur
Hanns-Christian Mahler; Wim Jiskoot
Éditeur
Wiley
Année de publication
2012
État de l'article
Good
Reliure
Hardcover
Langue
anglais
ISBN à 10 chiffres
0470497181
ISBN à 13 chiffres
9780470497180
Édition
1st Edition

killarneybooks

Inagh, Clare, Irlande

Vendeur avec une évaluation de 5 étoiles

Vendeur AbeBooks depuis 20 avril 2017

Frais d'expédition de Irlande vers Etats-Unis

Article6 à 7 jours ouvrés3 à 4 jours ouvrés
Premier articleEUR 33,70EUR 38,00
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All U.S.-bound orders are now shipped with UPS for reliable delivery. Additional customs or import fees are highly unlikely; however, please note buyers remain responsible for any duties or taxes that U.S. Customs may assess. -- Killarneybooks is a family-run bookshop based in the Republic of Ireland. We take pride in accurate listings, careful packaging, and prompt service - most orders ship within 24 hours. All books listed are in stock and ready for immediate dispatch - we are not dropshippers. Inquiries always welcome.…

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