The manufacture of AAV for gene therapy applications using a closed, semi-automated hollow-fiber bioreactor

viral genomes from 1.2 L of harvested cell lysate. The application of a standard AAV downstream process confirmed normal processability of the material. A cost of goods model comparing the Quantum bioreactor with the current standard HYPERStack36 and Corning CellSTACK 10-layer systems demonstrated that the Quantum bioreactor reduced the number of open steps by more than 40-fold, production time by up to 3.6-fold (HYPERStack36) and 7.5-fold (CellSTACK 10-layer), and costs by up to 2-fold (HYPERStack36) and 20.7-fold (CellSTACK 10-layer). Therefore, the Quantum bioreactor is an effective alternative to plastic flasks for the manufacturing of AAVs at both R&D and early translational scale, as it reduces production time, operating costs, and process risk.