作者: Mary E. M. Cromwell , Eric Hilario , Fred Jacobson
DOI: 10.1208/AAPSJ080366
关键词:
摘要: Protein aggregation is a common issue encountered during manufacture of biotherapeutics. It possible to influence the amount aggregate produced cell culture and purification process by carefully controlling environment (eg, media components) implementing appro-priate strategies minimize extent aggregation. Steps remove aggregates have been successfully used at manufacturing scale. Care should be taken when developing monitor compatibility equipment with protein ensure that potential minimized.