Predictive Algorithm Modeling for Early Assessments in Downstream Processing Using Direct Transition and Moment Analysis To Assess Chromatography Column Integrity at Production Scale

摘要

Failure to detect breaches in chromatography column performance can be disastrous during large-scale commercial manufacturing. Our company uses algorithm modeling for near-real-time monitoring of column packing quality and sensitive detection of columnintegrity breaches. The approach enables us to mitigate risks early on, save cost and time, and thereby deliver consistent product quality and purity during manufacturing.