title: Protein aggregation and bioprocessing.
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.
authors.affiliation: Early Stage Pharmaceutical Development, Genentech Inc, South San Francisco, CA 94080, USA. cromwell@gene.com
authors.forename: Mary E M
authors.initials: ME
authors.lastname: Cromwell
authors.forename: Eric
authors.initials: E
authors.lastname: Hilario
authors.forename: Fred
authors.initials: F
authors.lastname: Jacobson
mesh_terms: D018929:Cell Culture Techniques; D002626:Chemistry, Pharmaceutical; D057927:Hydrophobic and Hydrophilic Interactions; D010316:Particle Size; D011506:Proteins / Q000737:chemistry* / Q000302:isolation & purification
chemical_list: D011506:Proteins