Multilayer and Multiobjective Design Platform for Drug Product Manufacturing Processes of Biopharmaceuticals

Abstract

A platform is presented that enables systematic alternative generation and multiobjetive evaluation for designing biopharmaceutical drug product manufacturing processes. In the platform, the layers of product, unit operation, equipment technology, and operation are defined to assist generation of process alternatives as the combination of information at each layer. Multiple indicators are defined to evaluate economy, environment, supply, and product quality, which are aggregated to total score using weighting factors. A case study demonstrated that the developed platform can facilitate comprehensive process synthesis and multiobjective evaluation considering the novel disposable equipment technology for biopharmaceutical manufacturing known as single-use technology.