工业纯化工艺中疏水层析法对单抗多聚体去除的研究进展(英文)091016.pdfVIP

Current Pharmaceutical Biotechnology, 2009, 10, 427-433 427 Recent Advancement in Application of Hydrophobic Interaction Chroma- tography for Aggregate Removal in Industrial Purification Process 1,* 2 3 Yuefeng Lu , Brian Williamson , and Ronald Gillespie 1Global Process Engineering, Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA; 2Purification Proc- ess Development, Amgen Inc., Thousand Oaks, CA 91320, USA; 3Purification Process Development, Amgen Inc., Seat- tle, WA 98119, USA Abstract: Hydrophobic interaction chromatography (HIC) is a classic purification tool applied in protein and antibody, laboratory and industrial production process. It has been mainly used for the removal of both product-related impurities such as aggregates, as well as process contaminants such as host cell proteins. This review will focus on the recent devel- opment of HIC in its applications in the industrial purification processes. The process economy and requirements of high product purity and quality have driven much of the recent advancement in HIC chromatography in terms of increased throughput and enhanced selectivity or resolution. Meanwhile, high throughput screening (HTS), design of experiments (DoE) and platform approach for process development have been applied to shorten the development time. The through- put improvement has been achieved through new resins with increased binding capacity, using dual salts for load condi- tioning, and operating in the flow-through mode. In addition, hydrophobic interaction membrane filter chromatography technology reduces bed volumes and buffer usage and poten