Cost of Goods Modeling and Quality by Design for Developing Cost-Effective Processes

Increases in recombinant protein titers expressed in mammalian cells and cell culture process volumes have shifted the economic paradigm from upstream processing to downstream processing for the manufacturing of recombinant proteins, especially monoclonal antibodies (MAbs). Moreover, the pressure exerted by authorities on the healthcare industry to decrease the costs associated with treatments, and the recent entry of biosimilars into the market, have forced the biopharmaceutical community to find new solutions and strategies to reduce production costs. MAb process development currently is focused on the optimization of yield and throughput to deliver cost-effective processes. In this article, we describe the use of a cost of goods model in combination with a Design of Experiment approach for optimizing the capture step by affinity chromatography. The most economical operating conditions identified through this approach imply sacrificing some protein without affecting the quality of the final product.