(344f) A Cost-Benefit Analysis of Continuous Manufacturing Using Discrete Event Simulation

In the pharmaceutical industry, the demand for small volume, market specific products has increased in recent years. However, current batch processes do not allow the flexibility to meet smaller demands without a high cost of inventory and risk of discards. Continuous processing may offer advantages to traditional batch processing including shorter lead times, reductions in inventory, decreases in management overhead, and fewer discards or loss of tenders. However, the specific conditions which make continuous manufacturing beneficial are currently not well understood. To quantify the benefit and determine the conditions where continuous manufacturing is an attractive alternative for products, a discrete event simulation model was developed. The model compares continuous to batch tablet formulation processes under numerous different scenarios including; various market conditions, production planning strategies, capacity constraints, and production volumes. The model uses a product currently produced at a Merck production facility as a base case. The outputs from the model define the product, market, and production conditions best suited for a continuous manufacturing platform. This ultimately enables a mechanism for identifying products that are a good fit for a continuous manufacturing platform.