(372c) Performance Characterization and Scalability of Disposable Bioreactors

The availability of compact, flexible and modular biomanufacturing technologies using disposable technologies has enabled their widespread use for toxicology and clinical manufacturing. Such facilities not only have the advantage of smaller footprint compared to traditional stainless steel plants (e.g. SIP and CIP piping) but also offer benefits of modularity and flexibility and reduced build-out time. Disposable bioreactor platforms, when combined with high efficiency processes and downstream disposable technologies can transform the manufacturing paradigm. This presentation will describe the use of pilot scale disposable bioreactors (rocking platform as well as stirred tank) in cell culture process development applications, including mixing and mass transfer characterization, comparability to stainless steel bioreactor and scalability performance.