East Hills, NY (March 22, 2006) - - The new FDA initiative aimed at expediting the development of seasonal and pandemic flu vaccines underscores the universal drive to improve the quality and timeliness of vaccine availability. Whether targeting avian flu, cancer or bacterial diseases, all vaccine development and production processes benefit from the use of technologies that reduce the risk of contamination, improve harvesting, increase throughput and eliminate the need for cleaning and cleaning validation. Technologies that speed time-to-market and enhance the quality of next generation vaccines are the subject of a presentation given today at the World Vaccine Congress by Dr. Hélène Pora, Vaccine Application Development Director, Pall Corporation (NYSE: PLL). Dr. Pora focused on two key areas that can adversely affect the safe production of vaccines: cleaning and cleaning validation, and separation and purification.
"Thirty to fifty percent of all warning letters from the FDA are related to cleaning," says Pora. "The use of disposables, which eliminate both cleaning and cleaning validation, will clearly minimize the risk of non-compliance in the production of vaccines. The fact that 70 percent of development and production time is devoted to quality and safety controls underscores the importance of eliminating unnecessary steps like cleaning through the use of disposables."
The presentation identifies increased purity, better characterization, improved product stability, and simplified production and compliance as critical to improving quality and time-to-market of new vaccines.
She also discussed methods to significantly reduce the 30 or more steps required to separate and purify conjugate vaccines as another way to improve quality and time to market. Beyond efficiency benefits, Pora also points out the higher throughput of ultrafiltration over size exclusion chromatography. This is of particular importance during fractionation or protein and saccharide components of conjugate vaccines. These vaccines protect infants and young children from infectious diseases such as meningitis and invasive pneumonia.
Pora makes the case for the synergistic benefits of integrating TFF units and membrane chromatography into larger disposable systems using Pall's Centrasette? ultrafiltration technology and Mustang? membrane capsules as examples. She points to the elimination of cleaning and cleaning validation, improved operator safety, reduced cross-contamination risks, and lower installation, labor, and maintenance costs as reasons for adopting these technologies.
A disposable, pre-packed membrane column can remove contaminants at up to 100 times the speed of resin-based chromatography. Membrane chromatography is also shown to provide an efficient alternative to traditional resin chromatography for capture steps in virus- and plasmid-based gene therapy and vaccine purification applications, demonstrating the technology's application beyond contaminant removal.. This technology can therefore play a significant role in reducing production time, and enables the accelerated production of novel viral and DNA-based vaccines
Pora concludes that advanced technologies will not only improve capacity, flexibility and availability of new vaccines, but that they will also help shape regulatory policy of this $10 billion market.
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, pharmaceutical, transfusion medicine, semiconductor, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2005 were $1.9 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. Visit Pall at http://www.pall.com/.
Forward-Looking Statement This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at www.sec.gov.
Helene Pora's presentation takes place on March 22, 2006 from 3:45pm-4:15pm at the World Vaccine Congress (March 20-23, 2006) being held at the Four Seasons Hotel in Washington, DC.