Protein aggregation is an important concern when developing and manufacturing biotherapeutics since these subvisible aggregate particles have been associated with the adverse drug reactions. Protein aggregates may provoke adverse events through an unwanted immune response. And, regardless of mechanism of reaction, subvisible particle contamination has been a concern for manufacturers and regulators.
Therefore, it is important to quantify protein aggregation and particle formulation due to various stresses such as temperature, shear, high concentration and time. Values for particle concentration and size distribution allow direct comparison of samples and treatments. Such data is needed to guide formulation development, evaluate handling requirements, and monitor product quality.
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