Monoclonal antibodies are the fastest growing class of therapeutics. However, aggregation
limits their shelf life and can lead to adverse immune responses. Assessment and …

Aggregation of mAbs is a crucial concern with respect to their safety and efficacy. Among the
various properties of protein aggregates, it is emerging that their size can potentially impact …

Nonnative aggregation is a common degradation route for therapeutic proteins. Control of
aggregate levels inherently requires control and/or prediction of aggregation rates at …

Many human monoclonal antibodies display poor biophysical properties, such as low
stability and a propensity to aggregate. These unfavorable tendencies can be even more …

Purpose Characterization of the monoclonal antibody aggregation process and identification
of stability factors that could be used as indicators of aggregation propensity with an …

Protein aggregation remains a major area of focus in the production of monoclonal
antibodies. Improving the intrinsic properties of antibodies can improve manufacturability …

Aggregation is a common problem affecting biopharmaceutical development that can have a
significant effect on the quality of the product, as well as the safety to patients, particularly …

Long-term stability of monoclonal antibodies to be used as biologics is a key aspect in their
development. Therefore, its possible early prediction from accelerated stability studies is of …

Human monoclonal antibodies often display limited thermodynamic and colloidal stabilities.
This behavior hinders their production, and places limitations on the development of novel …

The analytical characterization of biopharmaceuticals is a fundamental step in the early
stages of development and prediction of their behavior in bioprocesses. Protein aggregation …