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A good scale down model should mimic the AAV production process at the final production scale, whether the final scale is intermediate or large, adherent or suspension. Though it may not be possible to miniaturize every aspect of upstream production, it is especially important for the model to achieve comparable cell expansion parameters and utilize a transfection process that is scalable. Accordingly, choosing the right vessels for cell scale-up/out and the appropriate transfection reagents are key to easing the transition from process development to manufacturing. As an example for adherent cultures: Corning® HYPERFlask® or Corning HYPERStack® 12 layer vessels can serve as the process development vessel for a final scaled-out production in HYPERStack-36 vessels; Corning CellSTACK® 1 layer vessel or CellSTACK 2 Culture Chambers model larger scale cultures in CellSTACK-10 or CellSTACK-40 Chambers; Corning CellCube® 10 Layer or CellCube-25 Layer Modules directly scale to CellCube-100 Layer Modules.
For suspension cultures, many bioreactor models are available in a wide-range of volumes for small through large scale cell culture. Once the cell culture platform is established, develop the transfection process with reagents that are specifically optimized for direct scalability.
Polyplus Transfections’ PEIpro and FectorVIR are designed for robust and reproducible transfections in adherent and suspension cells, respectively, to achieve high titer AAV yields from small scale process development through large scale clinical-grade manufacturing.