Vector production in an academic environment: a tool to assess production costs

Abstract

Generating gene and cell therapy products under good manufacturing practices is a complex process. When determining the cost of these products, researchers must consider the large number of supplies used for manufacturing and the personnel and facility costs to generate vector and maintain a cleanroom facility. To facilitate cost estimates, the Indiana University Vector Production Facility teamed with the Indiana University Kelley School of Business to develop a costing tool that, in turn, provides pricing. The tool is designed in Microsoft Excel and is customizable to meet the needs of other core facilities. It is available from the National Gene Vector Biorepository. The tool allows cost determinations using three different costing methods and was developed in an effort to meet the A21 circular requirements for U.S. core facilities performing work for federally funded projects. The costing tool analysis reveals that the cost of vector production does not have a linear relationship with batch size. For example, increasing the production from 9 to18 liters of a retroviral vector product increases total costs a modest 1.2-fold rather than doubling in total cost. The analysis discussed in this article will help core facilities and investigators plan a cost-effective strategy for gene and cell therapy production.

FIG. 1.

Vector manufacturing phases and categories of expenses. The figure depicts four phases of vector manufacturing and the three categories of expenses used in generating a costing model. Gray boxes represent costs that are similar for most vector production and can be standardized in estimating vector costs. Harvest costs (diagonal lined boxes) reflect differences in processing and volume difference in production and require customized cost estimates for each product.

FIG. 2.

Three options for cost analysis. The methods for generating cost estimates are depicted for the three pricing models available in the cost tool.

FIG. 3.

Costing tool graphics. The figure represents the numeric (A) and graphic (B) information provided on the Summary tab of the costing tool for a theoretical retroviral vector production. The three batch sizes represent 9-, 18-, and 27-liter productions with the top panel demonstrating the total vector production cost and the bottom panel illustrating the per liter cost estimated using the Campaign (white), Day Use (black), and Hybrid (gray) models.

FIG. 3.

Costing tool graphics. The figure represents the numeric (A) and graphic (B) information provided on the Summary tab of the costing tool for a theoretical retroviral vector production. The three batch sizes represent 9-, 18-, and 27-liter productions with the top panel demonstrating the total vector production cost and the bottom panel illustrating the per liter cost estimated using the Campaign (white), Day Use (black), and Hybrid (gray) models.

FIG. 4.

Cost analysis based on production activity. The figure represents a cost analysis for manufacturing a retroviral vector as a function of annual vector products generated assuming fixed supplies and annual personnel and facility costs and an average production time of 34 days. (A) The price per vector manufacturing was estimated using the three costing models based on the number of vectors generated annually. (B) The annual loss or gain of revenue based on the number of vectors generated annually.

FIG. 5.

Cost of vector production. The cost of vector production based on volume of material generated is illustrated for the three different costing models and an annual production of nine vectors per year. Numbers located above the columns for 18 and 27 liters represent the cost multiplier for the 9-liter costs.