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Analysis of Aggregates and Particles in Protein Pharmaceuticals
Hanns-Christian Mahler (Edited by), H–C Mahler (Author), Wim Jiskoot (Edited by)
9780470497180, Wiley
Hardback, published 23 March 2012
472 pages
24.4 x 16.5 x 3 cm, 0.798 kg
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.
Contributors ix Preface xiii Glossary xv 1 The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates ofTherapeutic Proteins 1 I Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles 9 2 Separation-Based Analytical Methods for Measuring Protein Aggregation 11 3 Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics 37 4 Online Detection Methods and Emerging Techniques for Soluble Aggregates in ProteinPharmaceuticals 61 5 Analytical Methods to Measure Subvisible Particulates 85 6 Detection of Visible Particles in Parenteral Products 117 7 Characterization of Aggregates and Particles Using Emerging Techniques 133 II Methods Used to Characterize Protein Aggregates and Particles 169 8 Ultraviolet Absorption Spectroscopy 171 9 Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles 201 10 Infrared Spectroscopy to Characterize Protein Aggregates 227 11 Raman Microscopy for Characterization of Particles 249 12 Microscopic Methods for Particle Characterization in Protein Pharmaceuticals 269 III Integrated Approaches to Protein Aggregation and Particles 303 13 Comparison of Methods for Soluble Aggregate Detection and Size Characterization 305 14 Protein Purification and Its Relation to Protein Aggregation and Particles 335 15 Formulation Development and Its Relation to Protein Aggregation and Particles 369 Index 389
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Subject Areas: Chemistry [PN]
