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 equipment for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire
Chapter three Laser gentle Scattering?Based concepts Used for the Characterization of Protein Therapeutics (pages 37–60): John den Engelsman, Fabian Kebbel and Patrick Garidel
Chapter four on-line Detection equipment and rising thoughts for Soluble Aggregates in Protein prescribed drugs (pages 61–84): Tapan ok. Das
Chapter five Analytical how you can 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 recommendations (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 equipment for Particle Characterization in Protein prescription 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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Additional info for Analysis of Aggregates and Particles in Protein Pharmaceuticals
Therefore, obtaining high precision requires careful maintenance of the instrumentation as well as additional steps to minimize both systematic and random noise. The wavelength and radial position accuracy as well as rotor temperature should be checked and calibrated regularly using reference or internal standards to ensure that the instrument is performing properly. The alignment of the AUC cell with the center of rotation can also be a factor . An alignment tool can be used to improve the precision and accuracy of measurements.
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. 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.
Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci 2010;99:2200–2208. 6. Singh M, Chakrapani A, D O’Hagan. Nanoparticles and microparticles as vaccine delivery systems. Expert Rev. Vaccines 2007;6:797–808. 7. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW. Heterogeneous nucleation-controlled particle formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation.
Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler, Wim Jiskoot