Cellexus Limited Gains ISO9001 Quality Management Accreditation

Published: Apr 20, 2010

Cellexus Limited, a leading supplier of innovative single use, disposable bioreactors which are designed to simplify and improve cell culture and fermentation bioprocesses, has gained formal ISO 9001:2008 accreditation. This International standard of certification illustrates that the Company has developed and implemented an effective quality management system, including a set of procedures that cover all key processes in the business as well as monitoring processes to ensure these are effective. It demonstrates the Company’s ability to consistently provide products that meet customer and statutory and regulatory requirements, as well as addressing customer satisfaction through effective application of the quality management system. Processes for continual improvement and prevention of defects and nonconformity and also included.

Mr Paul Stubbings, Cellexus Limited Chief Operating Officer, said in a statement, "We are delighted to announce our ISO 9001:2008 accreditation which certifies that we are applying formalised, professional business processes. It is illustrative of our commitment to our customers to provide high quality products and standards. We are regularly reviewing our business processes and our quality management systems for effectiveness and are continually striving for improvement to satisfy our customer’s needs. These systems and processes provide us with an even stronger foundation on which to build the business both in terms of our product portfolio as well as our geographical coverage. We will apply these systems and processes as we continue to expand the CellMaker range of bioreactor systems”

The CellMaker systems apply single-use, disposable cell culture bioreactor bags with highly efficient methods to mix and oxygenate. Whilst other systems require shakers, rockers, rollers or large environmental chambers, the CellMaker systems employ a novel airlift technology which is simple, scalable, inexpensive to use and proven to out-perform cell culture in flasks. The CellexusBags, which are the unique single-use, disposable cell culture bags in which cells are grown in the CellMaker systems, enable fast set-up times and eliminate cleaning requirements. The CellMaker systems very efficiently aerates the CellexusBag with controlled air flow providing oxygen for cell growth and gentle and effective mixing to maintain cells in suspension. Pressure control enhances oxygen availability to cells as well as decreases foaming and temperature control enables production of high yields of soluble protein under optimal conditions.

About Cellexus Limited

Cellexus Limited (Huntingdon, UK) provides a range of instruments and value added consumables to help researchers in the biopharmaceutical industry and academia develop new biopharmaceutical products from cell lines. Biopharmaceuticals are a rapidly evolving range of therapeutics generated by culturing cells in bioreactors and include proteins, antibodies or vaccines, with the possible of future medical treatments offered by stem cell research also falling into this category. Sales of biopharmaceuticals reached US$60 billion in 2005 and are growing at 20% per year. The Company’s core technology is at the centre of a range of different product configurations and formats the Company offers that can be used for production of biological cells and proteins in a single-use, disposable bag format. This same configuration can also be used in biopharmaceutical manufacture for mixing various materials under clean and sterile conditions. These product range offer significant technological improvements for cell culture and cell growth to the biopharmaceutical industry.

The single-use, disposable (consumable) element of the CellMaker bioreactors that the Company markets is the CellexusBag™. This single use, disposable self contained bag forms a product range which is manufactured under clean room conditions and to the ISO standards required by the biopharmaceutical industry. The bioreactor products come with built-in chiller units and an oxygen generator, which removes the need for piped gas. The gentle flow of gas bubbles mixes the contents and the bag design reduces foaming. The CellMaker equipment used to manage the cell culture process is very simple, efficient and inexpensive to use. A patent protecting the Company’s Intellectual Property in this area was filed in December 2005 with a second patent application filed in June 2007.

For further information please contact:

Cellexus Limited; Mr Paul Stubbings, Chief Operating Officer; Email: paul.stubbings@cellexusinc.com; Tel: +44 (0) 1480 414843; www.cellexusinc.com

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