A large part of the downstream processing of antibodies is the removal of aggregates. Aggregates can be formed both during the upstream cultivation and during the downstream processing and storage. Aggregate levels should be kept low to avoid batch failures and keep the product yield high. Most antibody platforms today contains several different chromatographic separation steps with storage tanks between each step. The antibodies are often eluted in harsh buffer conditions and at high concentrations which advances aggregate formation. It is therefore important to minimize the time spent in the disadvantageous conditions. This can be achieved by removing the intermediate storage tanks and instead using buffer exchange columns between the different chromatographic separation steps. The eluted pool from one column would then be the loaded onto the next column thus creating an integrated downstream processing.<br/><br/>This work presents a model-based comparison of the amount of aggregates formed using integrated and batch-wise downstream processing. It was found that removing the storage tanks could lower the amount of aggregates formed during the downstream processing.

Model-based comparison of protein aggregation in integrated and batch-wise downstream processing

249th National Meeting (2015)

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