Accelerating Technology Transfer Of A Drug Product Tangential Flow Filtration Process Through Collaboration

Moving a TFF process to a new manufacturing site requires more than equipment qualification. It depends on reliable evidence that the operation can scale, remain robust, and meet performance expectations. A collaboration between a major biomanufacturer and an MSAT team generated performance, cleaning, and reuse data for Pellicon® 2 cassettes used with the Mobius® TFF 80 single-use system. Findings supported increased membrane loading and cassette reuse, helping address throughput, scalability, and process requirements while lowering chemical and consumables costs by more than 35%.

Examine how structured testing and open information sharing can reduce uncertainty during technology transfer and create a stronger foundation for efficient biologics manufacturing at scale.