Development and implementation of tPA clot lysis activity assay using ACL TOP™ hemeostasis testing system in QC laboratories.

•An innovative design that allows fully automated, fully integrated clot lysis potency determination for lot release and stability testing.•A comprehensive validation design to ensure accurate estimate of recovery (accuracy) and precision profile.•A comparability strategy that allows justification of specification based on statistical comparison between assays.•Evidence of significant improvement in assay performance after being transferred to QC laboratories.