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 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 ideas for Soluble Aggregates in Protein prescription 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 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 strategies (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 mixture 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 wintry weather, 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
It provides expert reviews of the state-of-the art for the range of analytical methods used for assessment of protein aggregates and the numerous challenges that are unique to each method. Furthermore, the book provides insight into the future of method development and regulatory issues for protein aggregates. With comprehensive coverage of the key issues, this book will be a critical reference for the ﬁeld for many years. REFERENCES 7 REFERENCES 1. Rosenberg AS. Effects of protein aggregates: an immunologic perspective.
The common analytical methods for the analysis of protein aggregates include SEC, analytical ultracentrifugation (AUC), ﬁeld-ﬂow fractionation (FFF), and gel electrophoresis. These methods involve partial or complete separation of the different species and are mainly used to measure the levels of protein aggregates and determine their sizes. Recently, the AUC with a ﬂuorescence detection system (FDS) has also shown promise to measure protein self-association at high concentration directly in formulation buffer or human serum.
Although there is no physical separation of protein species in centrifuge cells during sedimentation equilibrium experiments, sedimentation equilibrium and velocity methods are closely related. Thus, we include the discussion of both methods in this chapter. The sedimentation velocity experiment is usually conducted at relatively high rotor speeds and the centrifuge run only takes a few hours to complete. Each protein species can form a unique boundary and sediment at a characteristic speed under a speciﬁed centrifugal force on the basis of its molecular mass and shape.