East Hills, NY (April 4, 2005) - - An increasing number of life-saving protein-based therapies are produced from cells that are grown in bioreactors using oxygen enriched air for aeration. While oxygen enrichment improves production yields and lowers overall processing costs, it can increase potential fire risks for sterilizing gas filtration operations. The new Emflon® CPFR sterilizing grade gas filter from Pall Corporation (NYSE: PLL) is specifically designed for such demanding fermenter or bioreactor applications by enabling manufacturers to use oxygen enrichment more safely. It is constructed of specially designed materials to reduce these hazards and improve overall safety.
Oxygen enrichment techniques, while highly productive, can lead to safety challenges because elevated levels of oxygen in bioreactor airflows can increase the risk of spontaneous ignition of conventional air sterilizing filter materials. The Emflon CPFR filter membrane is constructed of PTFE material, a widely used material that does not readily ignite. Additionally, the filter's support and drainage layers are designed using special materials to minimize combustibility, compared to polypropylene, a common material of construction in other gas filters.
As worldwide demand for fermentation and biotechnology products continues to rise, manufacturers are increasingly turning to oxygen enrichment techniques to maximize the levels of oxygen that reach cells, thereby promoting growth. More traditional technologies such as mechanical agitation or airlifting could be inefficient or not appropriate for certain types of cells (for example, mammalian cells used for biotech drug products) because they are sensitive to shear.
"This is the first filter for the oxygen-enriched aeration of mammalian cell culture and microbial fermentation operations that gives manufacturers a higher degree of safety," says Christian Martin, Ph.D., Product Manager, Pall Life Sciences, who will present data on the new filter today at the Annual PDA 2005 meeting in Chicago. "It enables drug producers to use modern aeration techniques safely, boosting cell culture yields and enabling a faster level of biotech drug production."
The Emflon CPFR filter was evaluated by the Federal Institute for Material Research and Testing in Germany ("Bundesanstalt für Materialforschung und-prüfung, BAM"), which routinely tests materials for usage in gaseous oxygen. The filter materials were subjected to pressure shock tests with 100 percent gaseous oxygen at 10-bar g (145psi) pressure at 60°C (140°F). The Institute concluded that the filter's materials had a high combustion resistance under rigorous testing, and were suitable for microbial and mammalian cell culturing applications using oxygen enrichment. The Emflon CPFR filter is also integrity testable using a Water Intrusion Test (WIT).
The Emflon CPFR filter also provides an additional benefit for sterile venting of water tanks when ozone is used to act as Marlyn, an antimicrobial and oxidizing agent. Unlike most sterilizing grade filters, the new filter has demonstrated higher resistance to and slower deterioration with ozonation.
Biotech drug production is expected to grow significantly over the next couple of years and aerobic fermentation--including mammalian and microbial cell culturing--is commonly used to produce a number of these valuable therapies. Gas and air filters used for fermentation protect nutrient media and cells in bioreactors against contamination by moulds, yeasts, bacteria, viruses, phages and other organisms that may be present in these fluids.
About Pall Corporation Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2004 were $1.8 billion. The Company headquarters are in East Hills, New York with extensive operations throughout the world.
Dr. Christian Martin will present "Sterilizing Filtration of Gaseous Oxygen for Cell Culturing Applications" at the 2005 PDA Annual Meeting in Chicago on Monday, April 4th at 2:00 pm.
The Emflon CPFR filter can be viewed at the Pall booth at PDA.