Biogen Idec Ma Inc.

Jörg Thömmes

Joydeep Ganguly

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.

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San Diego, CA, United States of America

Jörg Thömmes