(465c) Tff Applications in Large Molecule Bio-Pharmaceutical Production

This presentation will address uses of tangential flow filtration (TFF) in the Bio-pharmaceutical industry with a focus on large molecule Manufacturing. We will discuss different applications for TFF, the best control scheme for each application, and pitfalls of over-specifying or under specifying the system for the drug submission. The presentation will cover issues with TFF membrane failures and methods to predict integrity issues prior to having a gross failure during protein processing. The talk will also discuss CIP issues with large-scale membrane systems. It will also go into detail about steps followed to de-bottleneck a membrane operation in order to decrease cycle time. Finally the presentation will give an insight into GMP validation of membrane systems.