Fancy Romone M, Abraham David H, Taylor Matthew R, McMullin Cole, Brann Nicholas S, Bailey Daniel M, Brown David I, Horne Heather Bethea, Wolfe Leslie S
KBI Biopharma, Durham, NC, United States.
JSR Life Sciences, Sunnyvale, CA, United States.
Front Bioeng Biotechnol. 2025 Jun 5;13:1613174. doi: 10.3389/fbioe.2025.1613174. eCollection 2025.
To purify increasing amounts of biotherapeutics more efficiently, the use of high flow rates or greater resin bed heights during downstream chromatography steps is a tantalizing option. A limitation of utilizing high flow rates is the differential pressure generated by packed chromatography resin beds. As a resin bed height increases, the resin is susceptible to compression. By increasing the permeability of a packed resin bed through control of the hydraulic radius, column pressure-flow dynamics can be improved. Chromatography column performance using a commercially available Protein A resin was assessed with and without OMEGA, a column insert designed to modulate the hydraulic radius of the column by providing vertical supports through the packed resin bed. OMEGA was shown to reduce the effective hydraulic radius of packed resin beds, increase the permeability of packed columns by 44%-73%, and yield a 42%-50% decrease in pressure differential across the resin bed at a comparable linear velocity. The structural support provided by OMEGA enables higher operational flow rates and increased resin bed height without impact to either dynamic binding capacity or purified product quality. With the OMEGA column insert, scale-up hurdles are mitigated, and faster downstream processing times are unlocked across column geometries.
为了更高效地纯化越来越多的生物治疗药物,在下游色谱步骤中使用高流速或更高的树脂床高度是一个诱人的选择。使用高流速的一个限制是填充色谱树脂床产生的压差。随着树脂床高度的增加,树脂容易受到压缩。通过控制水力半径来增加填充树脂床的渗透率,可以改善柱压力-流量动态特性。使用市售的蛋白A树脂,在有和没有OMEGA(一种通过在填充树脂床中提供垂直支撑来调节柱水力半径的柱内插件)的情况下评估色谱柱性能。结果表明,OMEGA可减小填充树脂床的有效水力半径,使填充柱的渗透率提高44%-73%,并在可比的线速度下使树脂床两端的压差降低42%-50%。OMEGA提供的结构支撑能够实现更高的操作流速和增加树脂床高度,而不会影响动态结合容量或纯化产品质量。使用OMEGA柱内插件,放大障碍得以缓解,并且在各种柱几何形状中都能实现更快的下游处理时间。