– Sius(TM) is a breakthrough single-use product for Tangential- Flow-Filtration (TFF) applications in the downstream processing of Biopharmaceuticals. Sius(TM) provides economic savings as well as a better use of time and resources without compromising product quality or yield.

Novasep, a global leader in advanced separation technologies for downstream processing of biopharmaceuticals, introduced the firm’s first pre-sanitized single-use, ready-to-use cassette (Sius(TM)) at the 2008 BioProcess International Conference.

Single-use TFF Sius(TM) cassettes provide substantial economic savings over traditional re-usable TFF devices and offer optimum advantages over a wide range of operating scales. Although operating costs vary from site to site, the savings associated with single-use is measurable. For example, in one particular case, operating costs for a re-usable TFF process would be $28,000 USD while the cost of a single-use process would be $19,600 USD; representing a savings of approximately $8,400 USD per run (or +/- 30%). The annual savings of just this one TFF process would be approximately $500,000 USD with one run per week.

Using Sius(TM) also provides many other tangible advantages such as minimizing the risk of cross-contamination and a more consistent performance of the TFF process from run to run since each process occurs using a new membrane.

“With Sius(TM) cassettes, the time needed in preparing and cleaning the TFF single-use cassette is drastically reduced and thus, much more time is devoted to processing the product, increasing process efficiency and saving a significant portion of the overall process time” said Mark Perreault, Director of Membrane Development Biopharma, Novasep. “Single-use cassettes offer exceptional economic value when compared to reusable TFF cassettes.” Perreault added.

Pre-Sanitized Sius(TM) TFF cassettes are installed and used in processing after equilibration with buffer. With no need to flush or measure water permeability rates, Sius(TM) cassettes reduce the testing and set-up time and resources to perform these steps. Development work, scale-up and processing can be conducted nearly 50% faster by minimizing cleaning and validation procedures.