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. 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 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 tools and rising suggestions for Soluble Aggregates in Protein prescribed 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 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 thoughts (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 tools for Particle Characterization in Protein prescribed 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 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
2. Cordoba-Rodriguez R. Aggregates in MAbs and recombinant therapeutic proteins: a regulatory perspective. Biopharm Int 2008;21(11):44–53. 3. Philo JS. Is any measurement method optimal for all aggregate sizes and types? AAPS J 2006;8:E564–E571. 4. Philo JS. A critical review of methods for size characterization of non-particulate protein aggregates. 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.
3 Applications The AUC is one of the most versatile tools to study protein aggregation. Sedimentation velocity has been used to analyze molecules with sizes from nanometer to micrometer . It is an important orthogonal method to support SEC method development. 3 shows examples of an mAb after storage at −70 and 40◦ C for six months. The sedimentation velocity data were analyzed using SEDFIT to yield a size distribution of protein degradation products. The major degradation products, including two fragments peaks and several major aggregate peaks, were resolved by both the SEC (Fig.
The condition of labeling should be optimized and labeled protein should be characterized to ensure that the protein is not significantly altered. The method has high sensitivity, dynamic range, and speciﬁcity and allows for the detection of protein aggregates in more complex matrices such as highly concentrated protein formulations, cell culture media, and human serum. The speciﬁcity and sensitivity of an FDS are accomplished by using the ﬂuorescently labeled mAb as a reporter molecule, which is added at low concentration to the unlabeled mAb at a high concentration or complex biological media.