Downstream process development (DSP) is the systematic design, optimization, and scaling of purification processes used to isolate and refine a biological product from a complex harvest material following upstream cell culture or fermentation. It typically involves sequential unit operations including clarification, chromatography, viral inactivation, ultrafiltration/diafiltration (UF/DF), and sterile filtration, with the goal of achieving the required purity, yield, and CQAs in a scalable and GMP-compliant manner.
