By Hanns-Christian Mahler, Wim Jiskoot
Chapter 1 The severe desire for strong 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 equipment for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire
Chapter three Laser mild Scattering?Based innovations 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 thoughts for Soluble Aggregates in Protein prescription drugs (pages 61–84): Tapan ok. Das
Chapter five Analytical tips on how 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 suggestions (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 symbolize 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 tools for Particle Characterization in Protein prescribed drugs (pages 269–302): Patrick Garidel, Andrea Herre and Werner Kliche
Chapter thirteen comparability of equipment for Soluble combination 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 iciness, 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
In addition, LS from the large species may also contribute to the measured peak area, especially when the signal is collected at a low wavelength, such as at 214 nm. LS and viscometer detectors are mainly used to determine the size or MW of individual peaks. These methods have proved to be very useful to provide accurate assessment and characterization of different species . 2 Advantages, Challenges, and Key Considerations SEC methods that are used in virtually every laboratory provide rapid and precise measurements of protein aggregates.
Monoclonal antibody interactions with micro- and nanoparticles: adsorption, aggregation, and accelerated stress studies. J Pharm Sci 2009;98:3218–3238. 10. Lu Y, Harding SE, Rowe AJ, Davis KG, Fish B, Varley P, Gee C, Mulot S. The effect of a point mutation on the stability of IgG4 as monitored by analytical ultracentrifugation. J Pharm Sci 2008;97:960–969. 11. 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.
However, the method suffers from a few limitations that need to be carefully assessed. The separation is based on hydrodynamic volume of the different species rather than molecular mass. Therefore, large globular proteins may elute at the same place as smaller elongated or highly glycosylated species. This can result in signiﬁcant errors in determinations of MW if an MW standard of globular protein is used  as it has been shown previously by work on highly pegylated and glycosylated proteins where the extended sugar or polyethylene glycol residues lead to greater hydrodynamic volume and thus greater apparent MW .
Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler, Wim Jiskoot