Journal
AAPS JOURNAL
Volume 8, Issue 3, Pages E572-E579Publisher
SPRINGER
DOI: 10.1208/aapsj080366
Keywords
aggregation; self-association; cell culture; purification; filling; manufacture
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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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