There are many drivers to intensify the manufacturing of a biological product. Advances are occurring throughout the biomanufacturing arena, from process development techniques to improved manufacturing platforms, equipment and facilities. Many employ the term 'bioprocess intensification' to refer to systems for producing more product per cell, time, volume, footprint or cost. This need is being driven by two emerging priorities: cost control and process efficiency. We are seeing great interest in the power of such disciplines as synthetic biology, process simplification, continuous bioprocessing and digital techniques in the optimization of bioprocess development and manufacturing. Other powerful disciplines here include process automation, improved monitoring and prefabricated facility modularity and podularity.
Bioprocess intensificationDefining bioprocess intensification (BI) is difficult, for at least four reasons. First, the number of new biological products, from exosomes to DNA vaccines, makes even cataloging new initiatives difficult. Second are the many biomanufacturing advances, including new process development techniques and new manufacturing platforms, equipment and facilities. Third, intensification efforts include many advances in science and technology as they support diverse analytic, diagnostic and therapeutic product applications [1].The fourth difficulty relates to just what improvements in a process should be regarded as BI. Some have applied the term to most any process improvement, but many use it only when referring to getting more product from a process by producing more product per cell, time, volume, footprint or cost [2]. Used this way, BI refers to any activity that increases such common metrics as the cell-specific, volumetric or facility productivity. BI can be accomplished by such improvements as producing more product per time period upstream or retaining more quality product downstream. Defined this way, BI is a subordinate or supporting technology to the so-called nextgeneration or 'factory of the future' initiatives. BI can be enabled by such corollary technologies as continuous or digital biomanufacturing (Figure 1).Many process improvements affect values and metrics not in the original purview of BI. For example, a development initiative intended to improve product quality can also reduce failed batches and thereby increase a plant's annual productivity. Limiting the categorization of an activity to its primary, intended goals can increase clarity. We herein define BI as an activity intended to increase productivity by any metric.