In biopharmaceutical formulations, one of the key factors that manufacturers need to understand is the propensity of their samples to aggregate.
Aggregates in biologic drugs are undesirable as they reduce the amount of active ingredients in the sample. This reduces efficacy and immunogenic responses can be stimulated in the body. This can lead to more rapid clearance of the drug and again reduce efficacy, or in some cases can lead to severe immune responses.
Full characterisation of protein drug samples is necessary both for those developing formulations and those characterising final products. It is extremely important to have a technique that can both measure the amount of different protein aggregate components and identify and characterise each of them. In this way, a sample can be fully characterised and understood.