Chemie Ingenieur Technik, Vol.84, No.5, 633-645, 2012
Opportunities and Limitations of Disposable Technologies in Biopharmaceutical Processes
While the use of single disposable components in lab, pilot and production facilities is fully established, currently an adaptation of disposable technology for all unit operations, from media preparation to final filtration takes place. Major benefits, both for capital invest cost and for the time needed for implementing a new facility, are expected. An overview on the state of the art of disposable technology, both in upstream processing and in protein isolation and purification is given. Benefits and drawbacks of utilizing disposable technology are highlighted for selected unit operations. A conceptual design study for a monoclonal antibody plant delivers detailed insight into the potential of disposables. Finally, future opportunities and challenges of disposable technology are critically assessed.