Characterize, Identify and Quantify Protein Aggregates
Aggregation can form anytime during the biotherapeutic drug manufacturing, purification, storage, or handling process. Aggregation can have adverse effects, immune response, and cause efficacy of the drug to change.
No standard analytical method is available to measure all types of aggregates. Sensitive analytical techniques are necessary for monitoring the purity level of recombinant proteins and monoclonal antibodies (mAb) during formulation, storage, and clinical use. Size Exclusion Chromatography (SEC) coupled to UV detection and Agilent’s dynamic laser light scattering Multi-Detector Bio-SEC system can be used to analyze low levels of aggregation.
Agilent Technologies offers a number of high resolution inert SEC columns and detection systems to help scientists to routinely analyze and monitor aggregation and fragments from the main biopharmaceutical products.