By Hanns-Christian Mahler, Wim Jiskoot
Chapter 1 The serious want for powerful Assays for Quantitation and Characterization of Aggregates of healing Proteins (pages 1–7): John F. chippie, Barry Cherney and Amy S. Rosenberg
Chapter 2 Separation?Based Analytical tools for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire
Chapter three Laser mild Scattering?Based thoughts Used for the Characterization of Protein Therapeutics (pages 37–60): John den Engelsman, Fabian Kebbel and Patrick Garidel
Chapter four on-line Detection tools and rising strategies for Soluble Aggregates in Protein prescription drugs (pages 61–84): Tapan okay. Das
Chapter five Analytical the way to degree Subvisible Particulates (pages 85–115): Shawn Cao, Linda Narhi, Yijia Jiang and Rahul S. Rajan
Chapter 6 Detection of noticeable debris in Parenteral items (pages 117–132): Ronald Smulders, Hans Vos and Hanns?Christian Mahler
Chapter 7 Characterization of Aggregates and debris utilizing rising ideas (pages 133–167): Hui Zhao, Manuel Diez, Atanas Koulov, Mariola Bozova, Markus Bluemel and Kurt Forrer
Chapter eight Ultraviolet Absorption Spectroscopy (pages 169–200): Reza Esfandiary and Charles Russell Middaugh
Chapter nine Fluorescence Spectroscopy to represent Protein Aggregates and debris (pages 201–226): Robert A. Poole, Andrea Hawe, Wim Jiskoot and Kevin Braeckmans
Chapter 10 Infrared Spectroscopy to symbolize Protein Aggregates (pages 227–248): Marco van de Weert and Lene Jorgensen
Chapter eleven Raman Microscopy for Characterization of debris (pages 249–267): Stefan Fischer, Oliver Valet and Markus Lankers
Chapter 12 Microscopic equipment for Particle Characterization in Protein prescription drugs (pages 269–302): Patrick Garidel, Andrea Herre and Werner Kliche
Chapter thirteen comparability of tools for Soluble mixture Detection and measurement Characterization (pages 303–333): John S. Philo
Chapter 14 Protein Purification and its Relation to Protein Aggregation and debris (pages 335–367): Roberto Falkenstein, Stefan Hepbildikler, Wolfgang Kuhne, Thorsten Lemm, Hans Rogl, Eva Rosenberg, Gerhard wintry weather, Frank Zettl and Ralf Zippelius
Chapter 15 formula improvement and its Relation to Protein Aggregation and debris (pages 369–387): Miriam Printz and Wolfgang Friess
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Extra info for Analysis of Aggregates and Particles in Protein Pharmaceuticals
Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 2009;10:373–381. SECTION I Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles 2 Separation-Based Analytical Methods for Measuring Protein Aggregation ´ JUN LIU, BARTHELEMY DEMEULE, and STEVEN J. 1 INTRODUCTION Aggregation is one of the common degradation routes of protein pharmaceuticals and widely recognized as a critical quality attribute owing to its potential impact on product quality, safety, and efﬁcacy [1–3].
In addition, some of the negatively charged glycans can impact the migration of proteins. The SDS is a strong denaturant and can disrupt noncovalent association; therefore, the method is most useful for the detection of covalently linked protein aggregates. Although native gel electrophoresis can overcome some of these limitations of SDS-PAGE, it usually has poorer resolution. The CE-SDS and SDS-PAGE methods are quite easy to perform. The protein sample is ﬁrst treated with SDS at elevated temperature to ensure that the protein is fully unfolded and covered by SDS.
Liu D, Ren D, Huang H, Dankberg J, Rosenfeld R, Cocco MJ, Li L, Brems DN, Remmele RL Jr. Structure and stability changes of human IgG1 Fc as a consequence of methionine oxidation. Biochemistry 2008;47:5088–5100. 12. Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 2009;10:373–381. SECTION I Methods Used for Detecting, Quantifying, and Sizing of Protein Aggregates and Particles 2 Separation-Based Analytical Methods for Measuring Protein Aggregation ´ JUN LIU, BARTHELEMY DEMEULE, and STEVEN J.
Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler, Wim Jiskoot