Webinar | October 10, 2019

Facility Intensification And Cost Reduction Using An Integrated Buffer Delivery Platform

Source: MilliporeSigma

Downstream processing of monoclonal antibodies and other recombinant proteins requires large volumes of buffer to maintain pH and conductivity during chromatographic and ultrafiltration operations. A typical process requires more than 5 L of buffer in downstream purification operations for each liter of cell culture processed. The preparation of these buffers requires a large footprint for ‘buffer farms’ with mixing tanks, filtration equipment and storage tanks to meet the continuous demand for buffers for an overall facility. This has been cited as a bottleneck by many manufacturing facilities. The ability to outsource or implement a streamlined buffer preparation step has numerous benefits including reduced capital, labor, floor space, raw materials inventory, facility overhead and QC testing and release. With these benefits come some risks that pharmaceutical manufacturers must address before implementing a new buffer preparation strategy for these critical raw materials that are fundamental to manufacturing. These risks include raw material variability, accuracy of the buffer specifications, as well as stability and quality of the buffer upon transport and over time.