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Aggregation and Fragment Analysis

Identify and Quantify Protein Aggregates and Fragments

Aggregates that form due to improper production, storage, or handling conditions can have important consequences for the safety and efficacy of biopharmaceuticals. The presence of aggregates is undesirable for two reasons: first, small aggregates can lead to immune reactions; and second, particulates can cause adverse events upon administration.

Sensitive analytical techniques are necessary for monitoring the purity of recombinant proteins and monoclonal antibodies (mAb) during formulation, storage, and clinical use. The aggregates that form in these samples due to improper production, formulation, storage, or handling conditions can be separated and detected based on their difference in size from the main drug product. Typically, Size Exclusion Chromatography (SEC) coupled to UV detection is used to analyze aggregation and conformational variants in order to monitor the integrity of the investigated sample.

Agilent Technologies offers a number of resources and products to help scientists analyze and separate undesirable aggregates and fragments from biopharmaceutical products.