Optimizing Efficiency in High-Concentration Biopharmaceutical Production: In-Line, Concentration-Controlled Tangential-Flow Filtration

UFDF is a critical step in the downstream process that commonly uses tangential flow filtration (TFF) techniques. Traditional UFDF relies on mass-balance monitoring, which presents challenges such as variability across runs and the need for frequent sampling. As the demand for high-concentration monoclonal antibody (mAb) drugs rises, there's a growing pressure to optimize processes while maintaining critical quality attributes. Process Analytical Technology (PAT) offers a solution by enabling real-time protein concentration monitoring using ultraviolet-visible (UV-vis) spectroscopy through Variable Pathlength Technology (VPT). The KrosFlo FS-15 TFF system, incorporating VPT technology, allows for proactive control based on immediate concentration feedback, enhancing process efficiency and product quality. Through experimental validation across a range of high-concentration products, this approach demonstrated significant improvements in process control, reducing errors, and ensuring consistent quality throughout downstream development.

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