DIRECT MASS SPECTROMETRIC ANLAYSIS OF AGGREGATES OF THERAPEUTIC PROTEINS

The invention relates to a method of using high-mass matrix assisted laser desorption-ionization (MALDI) mass spectrometry for the quantitative analysis of the amount of aggregation (dimers, trimers or multimers) of antibodies or other therapeutic proteins in purified pharmaceutical samples or complex biological matrices, as well as to the use of this method for characterization of antibodies, drug development and quality control of therapeutic proteins, including automated high throughput applications.