(569c) Evaluating Biopharmaceutical Economics and Capacity with Process Simulation Tools

The capital investment for new biopharmaceutical manufacturing facilities is around $7000 per liter of bioreactor capacity. Moderate to large scale facilities can cost hundreds of millions of dollars, yet such investments are often made with uncertain information about process performance, media and materials prices, and market conditions. This paper presents a systematic way to evaluate the critical costs and capacity issues in biopharmaceutical plants. Examples will be presented on determining the target product titer, optimizing bioreactor batch size and choosing where or whether to use disposable (single-use) equipment. Since many process decisions must be based on partial or uncertain information, this presentation will also describe how to evaluate the risk associated with process and economic assumptions.