Copenhagen, 26th June 2008 - Upfront Chromatography A/S, the world´s leading developer of customized industrial-scale separation services has launched disposable adsorption units for capturing monoclonal antibodies. The disposable units adsorb therapeutic proteins directly from the bioreactor without the need for cleaning validation and clarification steps, such as filtration and centrifugation. This reduces the overall cost and environmental burden of manufacturing.
Monoclonal antibodies and antibody fragments continue to be a major discovery platform for therapeutic agents. Contract Manufacturing Organisations (CMO´s) and Pilot Plant facilities are under pressure to maximise their throughput of pipeline therapeutics without compromising on purity, quality and product safety. Disposable downstream processing units offer greater flexibility for manufacturing and have been shown to improve productivity in generating clinical trial materials.
Upfront´s integrated disposable chromatography system is based on its proprietary Rhobust™ universal processing platform. Rhobust™ has been implemented in a range of industrial settings for commercial-scale recovery and purification of functional biomolecules, including monoclonal antibodies, direct from crude feedstocks. A key feature of Rhobust™ is that it does not generate pressure during operation, thereby enabling construction of cost-effective, disposable columns from plastic. The combined advantages of disposability and crude feedstock processing have delivered a single high-yielding system which eliminates the requirement for pre-clarification of the feedstock.
"Using EBA as a disposable adsorption platform has some compelling advantages", commented Allan Lihme, CTO & Founder of UpFront Chromatography A/S, "Three processing operations are combined into just one disposable unit and because these systems do not generate any back-pressure, disposable tubing can be safely used in the pumping system rather than stainless steel piping that requires validated cleaning".
The Rhobust™ Flex disposable units are operated by a flexible pumping and data acquisition system, that itself requires minimal cleaning and uses disposable tubing to minimize cross contamination of clinical trial products. Clearance of cells and cellular debris is as complete as performing two clarification processes and a traditional packed bed adsorption procedure.
Upfront Chromatography will be displaying 2nd Generation EBA disposable chromatography purification system at WillBio - Single Use Components and Systems, July 28-30, in San Francisco, California, USA. Come and meet us at the Stand 14.
About disposable chromatography
Upfront´s integrated disposable chromatography system is based on its proprietary Rhobust™ universal processing platform. Rhobust™ has been implemented in a range of industrial settings for commercial-scale recovery and purification of functional biomolecules, including monoclonal antibodies, direct from crude feedstocks. A key feature of Rhobust, and in particular the disposable system, is that it does not generate pressure during operation: enabling construction of cost-effective, single-use columns from plastic. The combined advantages of disposability and crude feedstock processing has delivered a single high-yielding system which eliminates the requirement for both cleaning validation and further clarification steps, such as filtration and centrifugation.
About Upfront Chromatography
Upfront Chromatography A/S develops and manufactures innovative products and technologies for extraction and recovery of biotherapeutics, functional biomolecules, macromolecular complexes, and even living cells, directly from bioreactors and industrial side-streams.
For customised separation services, Upfront offers access to its proprietary universal process platforms combined with extensive technical and regulatory support. From a feasibility study to commissioning of the final installation, Upfront works with its customers to develop adsorbents, ligand chemistry, columns and other hardware to optimise process performance. Upfront´s research, development and ISO9001-compliant manufacturing facility is situated in Copenhagen, Denmark. Please visit: www.upfront-dk.com
For further information, please contact:
For further information, please contact:
Upfront Chromatography A/S
Natalya Clark,
PR/Marketing Manager
nac@upfront-dk.com
T: +45 39 27 37 63