Download e-book for iPad: Analysis of Aggregates and Particles in Protein by Hanns-Christian Mahler, Wim Jiskoot

By Hanns-Christian Mahler, Wim Jiskoot

ISBN-10: 0470497181

ISBN-13: 9780470497180

ISBN-10: 1118150570

ISBN-13: 9781118150573

Content material:
Chapter 1 The serious 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 tools for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire
Chapter three Laser gentle Scattering?Based strategies 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 prescribed drugs (pages 61–84): Tapan okay. Das
Chapter five Analytical how to degree Subvisible Particulates (pages 85–115): Shawn Cao, Linda Narhi, Yijia Jiang and Rahul S. Rajan
Chapter 6 Detection of seen 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 symbolize Protein Aggregates and debris (pages 201–226): Robert A. Poole, Andrea Hawe, Wim Jiskoot and Kevin Braeckmans
Chapter 10 Infrared Spectroscopy to signify 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 combination Detection and dimension 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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Additional info for Analysis of Aggregates and Particles in Protein Pharmaceuticals

Example text

The fluorescence signal of albumin was not from intrinsic fluorescence, but from albumin-bound fluorescent molecules, such as flavins and hemoglobin oxidation products [10]. The sedimentation coefficient of the antibody in human serum, once corrected for serum density and viscosity, was very close to what is expected for an intact mAb in PBS. In addition to albumin and mAb, a trace amount of a large aggregate species at ∼ 12s was also detected. This aggregate peak was not observed in PBS, but showed a similar size as intermediate complex formed by antibody and antigen, suggesting that it is likely due to the complex formed by omalizumab and the endogenous IgE.

2 ments. 17 Window Typical cell assembly for sedimentation equilibrium and velocity experi- side (Fig. 2). The concentration of proteins under a centrifugal field along the radial position can be determined at any given time by absorption, interference, and fluorescence optical systems. The UV/VIS absorption optical system measures protein concentration based on the fact that many macromolecular species such as protein and DNA contain chromophores that absorb incident light in the UV range. The concentration of macromolecules is calculated according to Beer’s law.

For the absorption system, it is important to avoid buffer or excipient components that have significant absorption at the wavelength of detection. For accurate quantification, it is important to avoid the use of thermodynamically nonideal conditions, such as low-salt and high-protein concentration, since most analysis software and mathematical models are not designed to handle nonideal systems properly. The detection wavelength should be selected within a flat region of the absorbance peak so that the absorbance signal is not significantly impacted by a small wavelength drift.

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Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler, Wim Jiskoot


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