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Bioprocessing

A Systematic Framework to Control Expression Drift from Selection Design to Industrial Acceptance

A Systematic Framework to Control Expression Drift from Selection Design to Industrial Acceptance

In modern biopharmaceutical manufacturing, the true determinant of long-term success is not how quickly a cell line reaches peak titer, but whether it can stay there—consistently, predictably, and compliantly—through extended passaging, process scale-up, and commercial production. As regulatory expectations tighten and cost pressures increase, expression drift, clonal instability, and late-stage CQA variability have become some of the most expensive and least forgiving failure points in biologics development.