Perspectives on the cost of goods for hPSC banks for manufacture of cell therapies

The manufacture of advanced cell-based medicines is often complex and costly and prone to the unexpected impacts on the manufacturing process and this is especially relevant for products derived from cultured cells 1 , 2 . The strategies adopted for the expansion and processing of cells can impact significantly on the ‘cost of goods’ (COGs) for the manufacturing process and control of these costs is a crucial element to facilitate an economically viable supply chain for advanced cell-based medicines 3 . Efforts to address COGs for cell-based medicines may start with increased efficiencies in the cell culture process (e.g., culture media usage, use of better defined media to reduce variation, increased batch-size) 4 . Evaluation of cost-effective manufacturing with human pluripotent stem cells (hPSCs) 5 as starting materials will need to include expansion of the stem cells, their processing, and testing 6 . However, whilst the broad and significant challenges which arise at the creation of these crucial starting materials have been addressed by others 7 , the variation in COGs between different sources of hPSCs in different jurisdictions have not yet been explored in detail. It is important to note that the definitions of raw materials may vary between jurisdictions and in some cases the term ‘starting materials’ is used for components that will persist in the final product such as the hPSC line used in manufacturing or vectors that are not eliminated after an iPSC line is established.

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