August 26, 2022

Assessing leachables risk over a complete single-use, mAb process

Single-use systems (SUS) in biopharmaceutical manufacturing give advantages such as improved flexibility and plant efficiency, but also raise concern for compounds leaching from the polymeric components and entering the process stream. In an article, process equipment-related leachables are mapped over a complete single-use mAb process at pilot scale.


Tags: Singe-use systems, leachables, Mab, manufacturing