Table 3.

Typical inputs for product cost calculations.

Parameter	Drug substance cost (DS)	Drug product cost (DP)	Packaging cost
General note	Main driver of DS costs are process yield and process scale	Largest contributor to DP costs is facility utilization	Largest contributor to packaging costs is the primary packaging material (e.g., vial, syringe)
Materials	Materials/consumables make up majority of variable costs for bulk production.	Standard materials/consumables make up small contributor. Specialty adjuvants will be incremental premiums.	Syringes can cost up to USD 1/unit Vials, stoppers, caps typically about USD 0.50/unit Lyophilized vaccines can require two vials (API and diluents) and process is costly.
Labor	Relatively small, overall contributor for automated facilities, large contributor for disposable equipment	Relatively small overall contributor	The packaging run size and configurations can become a significant cost determinant due to change over time
Overhead	Primarily fixed in nature but not large contributor due to productivity vaccine DS	Primarily fixed in nature (taxes, utilities, maintenance etc.) and can be large contributor.
Scale	Scale increases can reduce costs per unit: (COGS2/COGS1) = (Scale 1/Scale 2)(~0.4)	Depreciation can be significant cost on a per dose basis (i.e., depreciation of USD 8–10 M over 10 M units = USD 1/unit)