By Andrew Carass, Director of Technology Management and Shannon Ryan, Associate Director, Downstream Process Integration, BioContinuum™ Platform
Large volumes of many buffers are essential for bioprocessing operations including those used to manufacture monoclonal antibodies (mAbs), vaccines, plasma and viral vectors. While relatively simple to produce, buffer preparation can consume a significant amount of resources and space in a manufacturing facility. For example, in mAb manufacturing, five to ten liters of downstream buffer are typically required for one liter of bioreactor volume while fifteen to twenty different solutions are needed for a typical upstream and downstream workflow.
While buffer preparation is a core operation that can drive plant scheduling and capacity, it is not considered to be a value-add activity. Furthermore, considering the rapid intensification of upstream processes and the proportional relationship between buffer volume and drug product produced (Figure 1) it is easy to envision future bottlenecks due to buffer preparation and management. Selection of the ideal strategy for intensification of this core operation will ensure the greatest benefits are achieved.
As process intensification strategies become more widely adopted, there is increased recognition of the need for intensified buffer preparation to support higher throughput processes. These needs are actively being investigated by industry consortia including a BioPhorum Technology Workstream and associated activities with NIIMBL1.
This white paper describes a novel, integrated approach to intensified buffer preparation and how this strategy can increase process flexibility, efficiency and reduce costs.