Mahler, Hanns-Christian. Jiskoot, Wim. text bibliography Electronic books. enk Chicester John Wiley & Sons 2012 monographic eng

electronic resource

1 online resource (474 pages) 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. ANALYSIS OF AGGREGATES AND PARTICLES IN PROTEIN PHARMACEUTICALS; CONTENTS; Contributors; Preface; Glossary; 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins; I METHODS USED FOR DETECTING, QUANTIFYING, AND SIZING OF PROTEIN AGGREGATES AND PARTICLES; 2 Separation-Based Analytical Methods for Measuring Protein Aggregation; 3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics; 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals. 5 Analytical Methods to Measure Subvisible Particulates6 Detection of Visible Particles in Parenteral Products; 7 Characterization of Aggregates and Particles Using Emerging Techniques; II METHODS USED TO CHARACTERIZE PROTEIN AGGREGATES AND PARTICLES; 8 Ultraviolet Absorption Spectroscopy; 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles; 10 Infrared Spectroscopy to Characterize Protein Aggregates; 11 Raman Microscopy for Characterization of Particles; 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals. III INTEGRATED APPROACHES TO PROTEIN AGGREGATION AND PARTICLES13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization; 14 Protein Purification and Its Relation to Protein Aggregation and Particles; 15 Formulation Development and Its Relation to Protein Aggregation and Particles; Index. edited by Hanns-Christian Mahler, Wim Jiskoot. Includes bibliographical references. Pharmaceutical chemistry Protein drugs Analysis Chemistry Techniques, Analytical methods Pharmaceutical Preparations analysis Proteins pharmacokinetics Pharmacy Medicine QV25 .A53 2012 615.19 Mahler, Hanns-Christian. Chicester : John Wiley & Sons, ©2012 9781118150573 1118150570 9781118150542 1118150546 http://onlinelibrary.wiley.com/book/10.1002/9781118150573 http://onlinelibrary.wiley.com/book/10.1002/9781118150573 EBLCP 111212 20171116085825.0 ocn768082726 eng