Biogen Idec Ma Inc.

Joydeep Ganguly

Jorg Thommes

Asif Ladiwala

Paul Cunnien

Robert Song

Basav Ghosh

Jörg Thömmes

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.

Automated system and method for monitoring chromatography column performance, and applications thereof

Methods and systems for evaluating and/or monitoring chromatography column performance are provided. Embodiments apply multivariate analysis (MVA) methods to process data as well as transition analysis data to provide a comprehensive evaluation of chromatography column performance. In embodiments, transition analysis data generated over extended periods of time can be analyzed together with process data to evaluate column performance. Further, embodiments enable a compact and robust tool for combining and presenting performance evaluation results, which allows for time-efficient performance examination. According to embodiments, MVA methods applied on transition analysis and process data provide (1) near real-time ability to comprehensively monitor column packing quality; (2) sensitive detection of column integrity breaches; (3) sensitive detection of subtle changes in column packing; (4) sensitive detection of different types of changes in column packing; (5) sensitive detection of fronting/tailing; and (6) sensitive detection of changes in process performance.

Systems and methods for evaluating chromatography column performance

Growing community of inventors

Boston, MA, United States of America

Joydeep Ganguly