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Novasep Launches the Sius™ Single-Use TFF Skid, Completing the First 100 Pct Single-Use TFF Solution for Pre-Clinical to Clinical cGMP Biomanufacturing


2/14/2013 10:29:03 AM

Pompey, France, February 14, 2013 - Novasep, a leading supplier of purification solutions to the life sciences industries, today announces the launch of its Sius(TM) single-use tangential flow filtration (TFF) skid. The TFF skid completes the Novasep proprietary, single-use TFF solution for pre-clinical to clinical cGMP biomanufacturing. The new skid is the first on the market to offer a 100 per cent single-use TFF solution.

The Sius TFF skid is comprised of an automated bench top unit with a fully disposable flowpath and is extremely compact. It is capable of lab to pilot scale TFF operations. Eliminating the risk of cross contamination, the unit widens the market for disposable TFF solutions, accommodating surface areas from 0.1 square meters to 2 square meters for microfiltration and ultrafiltration/diafiltration (UF/DF) applications.

Novasep has achieved a 73 to 80 per cent reduction in consumable price to USD 800/ square meter, by designing the TangenX(R) Sius Single-use TFF cassettes to be more cost effective. This compares to USD 3000/ square meter to USD 4000/ square meter for competing products. The long term drive by the biopharmaceutical industry to reduce costs, including the costly effort of cleaning equipment and validation, makes it increasingly reliant on disposable technologies. These offer numerous benefits over traditional reusable technologies. One of the most important of these is a time saving of 50 to 70 per cent using Sius technology over traditional reusable TFF technologies.

The Novasep Sius TFF skid’s flowpath can be combined with TangenX Sius TFF cassettes and filter plate inserts with the option of a feed bag, to provide a complete single-use TFF solution from a single supplier for pre-clinical to clinical cGMP biomanufacturing. It is also one of the only solutions to enable cGMP validated integrity tests.

“As the biopharmaceutical market continues to evolve, demand continues to rise for more cost-effective and comprehensive solutions,” said Alain Lamproye, president of Novasep’s Biopharma business unit. “Novasep has reacted to this by concentrating on continuing to increase its product and service portfolio in the downstream processing marketplace and we will continue to do so. By launching Sius TFF Skid, Novasep now offers the first 100 per cent single-use TFF solution on the market whilst remaining very cost effective. We are also developing a larger scale Sius TFF skid to cover commercial scale applications.”

Novasep will be presenting the Sius TFF skid at the Disposable Solutions for Biomanufacturing tradeshow in Brussels on February 19-20, 2013.

About Novasep

Novasep is a global provider of cost-effective and sustainable solutions to produce active molecules at the required purity. Novasep’s unique offering includes process development services; purification equipment and turnkey processes; contract manufacturing services and complex active molecules to serve pharmaceutical; biopharmaceutical; agrochemical; fine chemical; food and functional ingredient and bio-industries.

http://www.novasep.com



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