Alternate Case 1: New Facility
To build on the model of our base case, which utilizes CMO production, we have also modeled the case in which a new greenfield single-product facility is built for and exclusively devoted to the production of rrBChE using the two-stage semicontinuous operating strategy. To do so, our models are adapted to consider CAPEX associated with purchasing and maintaining the required equipment and facilities. We calculated that the most cost-effective facility would have four complete sets of seed train equipment, four production bioreactors, and one set of downstream processing equipment (data not shown). The equipment and fixed capital costs are all scaled accordingly, along with all the facility-dependent OPEX contributions.
With these modifications, the cost of a 400 mg dose of rrBChE produced in a new facility is $573 when depreciation is included, and $389 when it is omitted, with CAPEX of $168 million (Table 3). The inclusion of facility-dependent costs increases the relative costs of the upstream processing from 21% in the CMO case to 62% with depreciation, which is expected as four full sets of upstream processing equipment are paired with one set of downstream processing equipment.