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Aggregation and Fragment Analysis

Identify and Quantify Protein Aggregates and Fragments

Aggregates can form during production, purification, storage, or handling. In some cases, these aggregates can have important safety and efficacy consequences.

Sensitive analytical techniques are necessary for monitoring the purity level of recombinant proteins and monoclonal antibodies (mAb) during formulation, storage, and clinical use. The aggregates that form during production, formulation, storage, or handling can be separated and detected based on their difference in size from the main drug component. Size Exclusion Chromatography (SEC) coupled to UV detection and Agilent’s Multi-Detector Bio-SEC system can be used to analyze aggregation and conformational variants.

Agilent Technologies offers a number of high resolution SEC columns and detection systems to help scientists analyze and separate these undesirable aggregates and fragments from biopharmaceutical products.