With increasing emphasis on biotherapeutics to meet unmet medical needs, continued scaling of global production and the introduction of new therapeutic modalities, we see a continuing need to develop bioprocesses faster and less expensively with assurance of high quality.

The strategy to achieve these goals involves three pillars: process intensification to reduce both variable and fixed costs, through high productivity, process integration to enhance speed of manufacturing and assure robust outcomes, and process interrogation to implement process control with online monitoring to assure constistent high product quality and minimal cost. These pillars provide a framework that provides guidance to those developing the tools and the processes supporting biotherapeutics manufacturing.