Analysis of aggregates and particles in protein pharmaceuticals /
[Book]
edited by Hanns-Christian Mahler, Wim Jiskoot
Hoboken, N.J. :
Wiley,
c2012
xvi, 443 p., [12] p. of plates :
ill. (some col.) ;
25 cm
Includes bibliographical references and index
The critical need for robust assays for quantitation and characterization of aggregates of therapeutic proteins -- Separation-based analytical methods for measuring protein aggregation -- Laser light scattering-based techniques used for the characterization of protein therapeutics -- Online detection methods and emerging techniques for soluble aggregates in protein pharmaceuticals -- Analytical methods to measure subvisible particulates -- Detection of visible particles in parenteral products -- Characterization of aggregates and particles using emerging techniques -- Ultraviolet absorption spectroscopy -- Fluorescence spectroscopy to characterize protein aggregates and particles -- Infrared spectroscopy to characterize protein aggregates -- Raman microscopy for characterization of particles -- Microscopic methods for particle characterization in protein pharmaceuticals -- Comparison of methods for soluble aggregate detection and size characterization -- Protein purification and its relation to protein aggregation and particles -- Formulation development and its relation to protein aggregation and particles