I have heard that there can be problems with leachables in single-use bags and recently read a paper in which Amgen identified bDtBPP as a culprit in lowering viable cell density. How has the issue of leachables been addressed and what are plans moving forward?

Answer

To date, we have not seen an issue with cell growth in Xcellerex products. Nevertheless, we have initiated efforts to interface with raw-material suppliers to better understand actions that might need to be taken to manage the specific issue that you have mentioned. These efforts are part of a larger mission to manage the overall supply chain for our products to assure product quality and availability. This is valid for both single-use products and multi-use products.