The ability of biopharmaceutical companies to develop manufacturing processes that deliver low costs of goods (CoGs) is becoming more important as the market becomes increasingly competitive. Process cost-modeling tools can be used to understand better the impact of process design and technology choices on overall process throughput and cost of goods. Biopharmaceutical companies can use these tools to determine whether they have a commercially viable process that will achieve the target cost of goods by predicting the impact of switching to alternative process con gurations and scaling-up.

Our process-modeling experts typically use the BioSolve Process software from Biopharm Services. They have received the highest levels of training and have gained signi cant experience through successfully delivering many diverse cost-modeling projects all over the world.

Process modeling can support biopharmaceutical companies during their early stage process development activities. Process development scientists use these tools to identify the most optimized process ows delivering the lowest costs. For analysis the software provides helps to identify speci c process steps with the potential to have the greatest impact on overall process economics. With this information, managers can direct scientists to invest their time and e ort into optimizing these unit operations and deliver the best overall outcome. For example, by using this tool we were able to identify that the steps in a MAb process with the highest costs were the production bioreactor in upstream processing and Protein A and cation-exchange chromatography step in downstream processing (Figure 1). We can also ascertain how the cost dynamics change with increasing titer. As the titer increases from 5 g/L to 10 g/L the importance of downstream processing costs increase signi cantly.