By Hanns-Christian Mahler, Wim Jiskoot
Chapter 1 The severe desire for powerful Assays for Quantitation and Characterization of Aggregates of healing Proteins (pages 1–7): John F. wood worker, 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 recommendations 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 recommendations for Soluble Aggregates in Protein prescription drugs (pages 61–84): Tapan ok. 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 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 prescribed 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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Extra resources for Analysis of Aggregates and Particles in Protein Pharmaceuticals
1a) and sedimentation velocity methods (Fig. 3). However, the sedimentation velocity method clearly shows better resolution of fragments and aggregates than those by the SEC method (Fig. 1a). In addition, more aggregate peaks were resolved by the sedimentation velocity method. Although the identities of those additional peaks are not fully understood and additional characterization work would be required to substantiate the presence of these peaks, the data clearly demonstrate the power of the sedimentation velocity method as an orthogonal method to monitor the size distribution of aggregates.
The CE is a relatively simple system that uses a narrow capillary rather than a large gel slab and requires very small quantities of samples. The sample loading, separation, and detection process can be fully automated. The CE can also be incorporated into a microchip ﬂuidic systems, which can largely increase the throughput of the analysis . 2 Advantages, Challenges, and Key Consideration for Method Development and Optimization Gel electrophoresis has provided a rapid and reproducible method to study protein size distribution.
The AUC essentially consists of a high-speed centrifuge with a precise temperature control, a rotor with several cell compartments, and optical systems that measure the concentration of proteins under any speed at a given time and radial position. 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.
Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler, Wim Jiskoot