Recent advancement in application of hydrophobic interaction chromatography for aggregate removal in industrial purification process.
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 development 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 throughput improvement has been achieved through new resins with increased binding capacity, using dual salts for load conditioning, and operating in the flow-through mode. In addition, hydrophobic interaction membrane filter chromatography technology reduces bed volumes and buffer usage and potentially improves process throughput by reducing cycle time. Selectivity and/or resolution enhancements have been achieved through optimization of operation parameters such as temperature and efforts such as application of solvent additives.
Lu
Yuefeng
Y
Global Process Engineering, Process Development, Amgen Inc., Thousand Oaks, CA 91320, USA. yuefengl@amgen.com
Williamson
Brian
B
Gillespie
Ronald
R
D001702:Biopharmaceutics / Q000639:trends; D005591:Chemical Fractionation / Q000379:methods; D002845:Chromatography / Q000639:trends*; D004345:Drug Industry / Q000639:trends*; D046912:Multiprotein Complexes / Q000737:chemistry* / Q000302:isolation & purification*; D011506:Proteins / Q000737:chemistry* / Q000302:isolation & purification*; D013678:Technology, Pharmaceutical / Q000639:trends*
D046912:Multiprotein Complexes; D011506:Proteins