A comprehensive strategy is in place to ensure the safety of LUXTURNA with respect to adventitious agents. This includes rigorous sourcing and testing of all raw materials of biological origin, including the HEK293 Master Cell Bank (MCB) and plasmids. The manufacturing process incorporates viral clearance steps, and the final drug substance and drug product are subjected to a battery of tests for bacteria, fungi, mycoplasma, and specific viruses as per regulatory guidelines, ensuring the product is free from microbial and viral contaminants.