[Determination of the particle size and relative light scattering intensity of aggregates of human IgG and humanized monoclonal antibody product induced by various stress using dynamic light scattering].

Abstract

To evaluate the usefulness of dynamic light scattering for the analysis of aggregates in the manufacturing process of monoclonal antibody and its final product, the particle size and relative light scattering intensity of aggregates of human IgG and humanized monoclonal antibody product induced by various stress such as stirring, increasing temperature, shaking and freeze-thaw were determined using dynamic light scattering. It was found that 1.3% of relative light scattering intensity as the minimum range and the range of particle size from 28.91nm to 3,000 nm of aggregates induced were determined by dynamic light scattering. These findings indicate that dynamic light scattering is useful for the in-process control tests of aggregates during the manufacturing and evaluation tests of aggregates for final products including the formulation and the storage. Some points well taken at the application of dynamic light scattering are discussed from the viewpoint of its merits and demerits.