Analysis of Aggregates and Particles in

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.

Hanns-Christian Mahler is Head of Pharmaceutical and Device Development. Pharma Technical Development Biologies Europe at F. Hoffmann-La Roche Ltd. He is also Lecturer at the Institute for Pharmaceutical Technology at the University of Frankfurt/ Main, Germany. Wim Jiskoot is Professor and Head of the Biologies Formulation Group in the Leiden/ Amsterdam Center for Drug Research (LACDR) at Leiden University.

Contributors	p. ix
Preface	p. xiii
Glossary	p. xv
The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins	p. 1
Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles	p. 9
Separation-Based Analytical Methods for Measuring Protein Aggregation	p. 11
Laser Light Scattering-Based Techniques Used for the Characterization of Protein Therapeutics	p. 37
Online Detection Methods and Emerging Techniques for Soluble Aggregates in Protein Pharmaceuticals	p. 61
Analytical Methods to Measure Subvisible Particulates	p. 85
Detection of Visible Particles in Parenteral Products	p. 117
Characterization of Aggregates and Particles Using Emerging Techniques	p. 133
Methods Used to Characterize Protein Aggregates and Particles	p. 169
Ultraviolet Absorption Spectroscopy	p. 171
Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles	p. 201
Infrared Spectroscopy to Characterize Protein Aggregates	p. 227
Raman Microscopy for Characterization of Particles	p. 249
Microscopic Methods for Particle Characterization in Protein Pharmaceuticals	p. 269
Integrated Approaches to Protein Aggregation and Particles	p. 303
Comparison of Methods for Soluble Aggregate Detection and Size Characterization	p. 305
Protein Purification and Its Relation to Protein Aggregation and Particles	p. 335
Formulation Development and Its Relation to Protein Aggregation and Particles	p. 369
Index	p. 389
Table of Contents provided by Ingram. All Rights Reserved.

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Analysis of Aggregates and Particles in Protein Pharmaceuticals

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