A large part of antibody manufacturing is the removal of aggregates. Some of the aggregates are generated during the upstream cultivation, but aggregation can also occur during downstream processing and storage. Aggregates are known to cause adverse effects such as immunogenic responses and if aggregates are generated in the downstream process, this will imply a loss of product yield. This work presents a model of the aggregation kinetics in solution. IgG was incubated at varying pH, salt concentration and temperature and analyzed by size exclusion chromatography at regular intervals. The reaction proved to be reversible, why the loss of monomers easily could be minimized.

Model based approach to study of IgG aggregation in solution

245th National Meeting (2013)

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