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%.