Implementing A Single-use TFF System In A cGMP Biomanufacturing Facility

For a multi-product cGMP manufacturing facility, measures to prevent risk of cross-contamination between products are a high priority. Single use technology can provide a simple method of achieving this goal for many processing
operations. This case-study describes how the transition from multi-use to single-use Tangential Flow Filtration (TFF) was evaluated and implemented for a buffer exchange step in a 500L production scale recombinant protein manufacturing facility (PF1) at CMC Biologics, a Contract Manufacturing Organization (CMO).

For a multi-product cGMP manufacturing facility, measures to prevent risk of cross-contamination between products are a high priority. Single use technology can provide a simple method of achieving this goal for many processing  operations. This case-study describes how the transition from multi-use to single-use Tangential Flow Filtration (TFF)  was evaluated and implemented for a buffer exchange step in a 500L production scale recombinant protein manufacturing facility (PF1) at CMC Biologics, a Contract Manufacturing Organization (CMO).