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Review
. 2006 Sep 15;8(3):E572-9.
doi: 10.1208/aapsj080366.

Protein aggregation and bioprocessing

Mary E M Cromwell  1 , Eric Hilario, Fred Jacobson
Affiliations
Review

Protein aggregation and bioprocessing

Mary E M Cromwell et al. AAPS J. .

Abstract

Protein aggregation is a common issue encountered during manufacture of biotherapeutics. It is possible to influence the amount of aggregate produced during the cell culture and purification process by carefully controlling the environment (eg, media components) and implementing appropriate strategies to minimize the extent of aggregation. Steps to remove aggregates have been successfully used at a manufacturing scale. Care should be taken when developing a process to monitor the compatibility of the equipment and process with the protein to ensure that potential aggregation is minimized.

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