Cellexus Limited And Groton Biosystems Collaborate on Use of Automated Sampling With Single-Use Bioreactors for Aseptic Sample Extraction from Cell Culture

Cellexus Limited, ’The Cell Company’, and Groton Biosystems are delighted to announce a collaboration on use of the Groton Biosystems automated sampler with the Cellexus single-use bioreactors for aseptic sample extraction from cell culture for improved cell culture process monitoring. Use of these systems combines advantages of production of the highest yields of soluble proteins under optimal conditions using the Cellexus CellMaker single-use bioreactors with ability to automate easy, quick and safe sample extraction under sterile conditions using the Groton Biosystems autosampler. This combination eliminates contamination and enables efficient cell culture monitoring for best protein production results. Accessing bioreactor/fermenter contents in this way is an important activity for any user. Ability to monitor, assay and record parameters, off-line from the bioreactor/fermenter, is an essential part of the daily routine in biochemical research and biopharmaceutical production.

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

Groton Biosystems supplies a family of on-line bioreactor autosamplers that sample from up to eight reactors and deliver samples to up to four analytical instruments. The ARS series, designed to be aligned with the FDA’s process analytical technology initiative, are ideal for reducing product development cycles, maximising R&D and production results, and tracking overall product quality. Users have also seen significantly improved product yields as a result of efficiencies created.

Mr Bob Cumming, Cellexus Limited General Manager, stated “We are very pleased to be working with Groton Biosystems. Laboratory environments can sometimes be far from sterile or clean, so taking samples from bioreactors and fermenters can result in bacterial, viral or chemical contamination. Losing a culture due to contamination can be costly and put vital projects in jeopardy because of the nature of the expensive media used and in the time lost in having to restart the cell culture. The Groton Biosystems autosampler provides an elegant solution to eliminate these risks. We are committed to a programme of product development to meet users’ needs. Having launched the CellMaker Regular single-use bioreactor system in October 2008 for bacterial and yeast cell we will be launching a range of other products in the coming months, including the CellMaker PLUS™ for culturing most cell types including mammalian and insect cell lines”.

Dr. George Barringer, Chief Scientific Officer of Groton Biosystems, added “The collaboration between Cellexus and Groton represents cutting edge technology in biopharmaceuticals. The connection of single use bioreactors with the Groton Automated Sampler will result in higher yields, higher quality, lower contamination rates and far lower operating costs for users. We are very pleased to be working with Cellexus on this project”.

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 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 (consumable) elements of the CellMaker bioreactors the Company markets are the CellexusBag™ and HybridBag. These single use self contained bags form a product range (there are currently six variants of the CellexusBag™ and two variants of the HybridBag) which are 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; Bob Cumming, Director and General Manager; Email: bob.cumming@cellexusinc.com; Tel: +44 (0) 1480 414843; www.cellexusinc.com

About Groton Biosystems

Groton is a pioneer in providing biotechnology companies with leading edge online and laboratory process monitoring solutions with a focus on biopharmaceuticals. Groton offers the most cost effective solutions for monitoring the entire research and manufacturing process for cell culture and fermentation with products designed specifically for companies whose processes require a bioreactor or fermenter and would benefit from an online sampling system to improve their efficiency.

Groton is an ISO and CE certified analytical equipment manufacturer headquartered in Boxborough, Massachusetts. In addition to complete in-house manufacturing, their 14,000 square foot state-of-the-art facility is equipped with a methods development laboratory to provide customers with on-site application services.

For further information contact: Groton Biosystems - Carol Stanton, VP of Marketing; Email: carol.stanton@grotonbiosystems.com; Telephone: 978-268-2902; www.grotonbiosystems.com

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