Protein aggregation and bioprocessing

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 strategi...

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Bibliographic Details
Published inThe AAPS journal Vol. 8; no. 3; pp. E572 - E579
Main Authors Cromwell, Mary E M, Hilario, Eric, Jacobson, Fred
Format Journal Article
LanguageEnglish
Published United States Springer-Verlag 15.09.2006
Subjects
Cell Culture Techniques
Chemistry, Pharmaceutical
Hydrophobic and Hydrophilic Interactions
Particle Size
Proteins - chemistry
Proteins - isolation & purification
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Summary: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.
Bibliography:ObjectType-Article-2
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ISSN:1550-7416
1550-7416
DOI:10.1208/aapsj080366