A commercial manufacturing process that has been established at BI for over 25 years and is still running was redeveloped. The goal was to optimize N-1 perfusion for media exchange. Therefore, state-of-the-art TFF filtration systems for 2000 L scale were evaluated.

Two challenges were predominant. First, suitable TFF filters with high performance that are GMP ready, inline-sterilizable and scalable to 2000L scale (stainless steel) needed to be found. The second challenge was to find a high-performance pump that creates minimum shear stress to the cell culture during perfusion over 3 – 5 hours in 80L and 2000L scale.

The solution was to integrate a Levitronix^® pump into a new TFF-filtration system in both, 80L development and 2000L manufacturing scale.