Monoclonal antibody purification and its progression to commercial scale

With the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtration and volume handling, must be considered while designing a facility for commercial scale. If any of these critical parameters are not defined during the facility design stage, collapse of the process can result, further resulting in commercial loss and delaying entry of the product into the market. Therefore, during the facility design stage, the process requirements, space utilization, process efficiency and advanced manufacturing systems must be evaluated appropriately before implementation on a commercial scale.