Real-time stability data from three PPQ lots support a shelf-life of 24 months for the LUXTURNA concentrate and the Diluent kit when stored at ≤ -65°C. Key attributes, including potency, titer, sterility, and container closure integrity, remain within specification throughout the study period. In-use stability studies show that the diluted product is stable for up to 4 hours at room temperature, providing adequate time for preparation and administration in the surgical suite.