公开(公告)号：US20140067308A1

公开(公告)日：2014-03-06

申请号：US14041318

申请日：2013-09-30

Applicant: Biogen Idec MA Inc.

Inventor： Paul CUNNIEN ,  Joydeep GANGULY ,  Basav GHOSH ,  Asif LADIWALA ,  Robert SONG ,  Jorg THOMMES

IPC: G01N33/00

CPC classification number: G01N33/00 ,  G01N30/34 ,  G01N30/8617 ,  G01N30/8693 ,  G01N30/88 ,  G01N2030/562 ,  G01N2030/889

Abstract: The present invention provides automated systems and methods for monitoring column performance in process chromatography, and applications thereof. In an embodiment, column performance is monitored by generating a plurality of process values such as, for example, conductivity values or pH values with a detector during a chromatography step transition between a first mobile phase liquid and a second mobile phase liquid. The process values are transformed to form transformed process values in which noise present in the process values is suppressed. Column performance parameters are calculated based on the transformed process values and displayed during movement of the second mobile phase liquid through the chromatography column. The displayed performance parameters enable an operator to make a determination, for example, regarding the quality of the chromatography column packing and whether to continue the chromatography process or stop the chromatography process until the chromatography column can be repacked or replaced.

Abstract translation: 本发明提供了用于监测过程色谱中色谱柱性能的自动化系统和方法及其应用。 在一个实施方案中，通过在第一流动相液体和第二流动相液体之间的色谱步骤过渡期间通过产生多个过程值，例如电导率值或pH值来监测色谱柱性能。 过程值被转换以形成其中抑制存在于过程值中的噪声的变换过程值。 色谱柱性能参数是基于转化过程值计算的，并在第二流动相液体通过色谱柱移动期间显示。 显示的性能参数使得操作者能够例如关于色谱柱填充的质量以及是否继续色谱法或停止色谱法以确定色谱柱可以重新包装或更换。