The Use of Critical Process Analysis to Reduce Risk and Increase Biologics Product Quality
Quality by Design in biopharmaceutical manufacturing processes includes the identification of critical process steps and parameters and the use of rational design to reduce risk and increase product quality. Unlike traditional pharmaceutical products, the manufacture of biopharmaceuticals involves production of the desired product in a living host organism followed by recovery and purification of the product from contaminating host and culture components. Using previous knowledge of process performance, product quality, comparable process issues when similar products or production systems are used, and overall system performance, those materials or operations that may impact product quality and safety can be properly identified and reliable, robust processes can be developed to address each potential risk area. In the case of monoclonal antibodies, critical process analysis of the manufacturing processes, process parameters, and outcomes from previous antibody products allows one to fully optimize the new production process in less time and with lower risk. Examples such as the optimization of Protein A affinity chromatography or the removal of specific process contaminants such as nucleic acids or viruses will be presented to demonstrate how the use of Quality by Design can not only improve overall product quality but also reduce costs and speed candidate products through clinical development more efficiently.