Base Case Process Economics
In the base case simulation, we assume the described process will be performed in a contract manufacturing facility (CMO) rather than a new facility to be used exclusively for this process. This can be economically favorable for low to moderate volume drug products, especially those with intermittent demand requirements that can be stockpiled such as BChE. Therefore, all facility-dependent costs, such as equipment maintenance, insurance, local taxes, factory expense, and depreciation, are excluded from determination of the drug price, and an extra 20% is added to the operating costs to account for a fee charged by the CMO.
A summary of production costs for base case process scenarios is shown in Table 3. Given the stated base case design parameters, a single batch produces 2.7 kg of pure rrBChE for total OPEX of $1.5 million, which corresponds to a unit production cost of $656/g or $263 per 400 mg dose. Upstream processing comprises 21% of the OPEX, while downstream processing costs comprise the remaining 79%.