CHARACTERIZATION OF PARTICULATES USING ELECTRON MICROSCOPY AND IMAGE PROCESSING METHODS

摘要

Methods and compositions for characterizing particles in a size range from about 1 micrometer to about 10 nm, and preferably 5 micrometer to about 5 nm. Using transmission electron microscopy and digital image processing techniques, the methods of the present invention can provide detailed information on the aggregation state of proteinacous samples such as antibody-based pharmaceutical compositions. The methods permit assessment of the effect of storage, use, processing, and shipping conditions in such proteinaceous samples.