By Hanns-Christian Mahler, Wim Jiskoot
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 equipment for Measuring Protein Aggregation (pages 9–36): Jun Liu, Barthelemy Demeule and Steven J. Shire
Chapter three Laser mild Scattering?Based options 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 recommendations for Soluble Aggregates in Protein prescription drugs (pages 61–84): Tapan okay. Das
Chapter five Analytical the right 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 concepts (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 signify 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 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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Extra info for Analysis of Aggregates and Particles in Protein Pharmaceuticals
Curr Pharm Biotechnol 2009;10:358–372. 5. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G. 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.
The sedimentation of proteins under the lower centrifugal ﬁeld is opposed by diffusion and buoyancy, and eventually when they reach equilibrium, a time-independent exponential concentration gradient of the protein is established throughout the centrifuge cell. The concentration gradient at equilibrium can be rigorously described by the ﬁrst principle of thermodynamic theory and has been widely used to determine the MW, stoichiometry, binding afﬁnity, and virial coefﬁcient of interacting or self-associating proteins .
The sedimentation coefﬁcient distribution from this method has a much improved resolution and covers a broader size distribution, since it explicitly corrects for the broadening due to diffusion and all the scans can be used in the analysis. In addition, this method includes a sophisticated regularization routine to help in removing spurious peaks that are caused by the noise in the raw data. This method has been widely used in the biopharmaceutical industry for monitoring the size distribution of aggregates.