The drug product is manufactured under strict aseptic conditions in a Grade A environment. The process involves:
1. Thawing the voretigene neparvovec drug substance bulk.
2. Aseptic pooling of the drug substance.
3. Aseptic filling of the concentrate into sterile 2 mL cryovials.
4. Aseptic filling of the Diluent into sterile 2 mL glass vials.
5. Stoppering and crimping of all vials.
6. Visual inspection, labeling, and packaging of the final kit.
Critical controls include environmental monitoring, validated filter integrity, and fill volume accuracy.