Most cell therapies are for the treatment of individuals, so your scale remains relatively small; rather than scale up, you scale out. However, when you scale out, labor becomes a big factor as many things must be run in parallel. This includes receipt of materials and batch record review, in order to manufacture the amount needed for your indication. With allogeneic cell therapy, although you will have to scale up at some point, those volumes are still quite small – less than 200L. In those cases, the unit operation time needed to process the volume is your stumbling block because the longer it takes, the bigger impact it will have on viability.
Other things can impact the cost to manufacture your drug. The cost of manufacturing location can vary – West Coast, East Coast, Europe – but closing your process can help reduce the cost of building your manufacturing plant. If your process is closed already, you could manufacture in a grade C or even D environment instead of grade B or A. It will also reduce operational cost because of less gowning requirements needed for the lower grade area. Whether you are working with a frozen in/frozen out product vs fresh in/fresh out product can also have an impact. A frozen product gives you more flexibility to when the product needs to be released, tested and shipped. A fresh product can lead to complex supply chain and delivery challenges, especially around the collection site and timings of delivery and shipping.