I know this is a complex question but can you give a high level about cost and if you see cost savings and where.


Continuous manufacturing is quite flexible and can be utilized at various production scales and configurations. Regardless of the case-by-case cost structure of every process, we will try to identify a few key factors that could significantly affect the cost of a continuous manufacturing process, in comparison to conventional processes. Generally speaking, continuous upstream processes can be cost effective when high volumetric productivity is achieved.  Often this means a smaller (and less expensive) bioreactor can be used compared to fed-batch processes and therefore the facility or manufacturing suites footprint can be smaller as well and thus more efficient on a square foot perspective leading to cost saving in CAPEX and facility occupancy. In addition, the cost of disposable raw materials will be lower per product because fewer batches are required to achieve the same product demand levels and the longer duration of each batch manufacturing run increases the utilization of the single-use materials.  Specific labor cost could also be reduced in case of 1) high volumetric productivity at moderately large scale, 2) higher automated process controls and 3) minimal turnaround work particularly with the implementation of single-use technologies and fewer turnaround activities (on a yearly basis) due to longer production duration. Price of media is a key factor that affects the production costs as media consumption will be somewhat higher compared to a fed-batch process, but the aforementioned cost reductions/savings can negate this potential disadvantage. For continuous downstream purification (and here we’re using a continuous product capture step as an example), the one-time cost of resin is reduced dramatically. The buffer usage may be reduced as well. Even though the initial downstream equipment costs are higher to implement continuous downstream processes, overall, the total costs for this step on a product by product basis are reduced through a continuous processing approach.

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