East Hills, NY (April 20, 2005) - - Viral vaccine development is a long and costly process governed by stringent regulatory controls. As the demand for vaccines increases globally, biopharmaceutical companies need to safely and reliably speed up development and production cycles that typically last 8 to 12 years and cost between $300 and $800 million USD. In a presentation today at the World Vaccine Congress, Dr. Hélène Pora, Pall Corporation (NYSE: PLL), describes how the use of disposable and scalable technologies to purify large molecule vectors, such as for gene therapy and cancer vaccines, can help manufacturers streamline the process and overcome many of the unique challenges associated with vaccine development.
Her presentation reviews advanced approaches to purification as part of a total process management scheme to help vaccine manufacturers address issues of scalability, validation and process development. Disposable processing systems can be installed in practically every part of the vaccine development cycle from cell fermentation and harvesting to downstream processing steps. Disposables offer lower installation costs compared to stainless steel systems and eliminate cleaning and cleaning validation. These factors significantly lower labor and maintenance costs and reduce the time required for scale-up procedures. Disposables also reduce the risk of cross-batch contamination and of worker exposure to the biohazards inherent in vaccine development.
"The use of scalable and disposable technologies can significantly improve process economics by eliminating time-consuming steps, safety risks, and several sources of capital and recurring expenses," says Dr. Pora. "With the cancer vaccine market predicted to reach $6 billion by 2010, efficient production will require flexibility and scalability. Disposable technologies capable of efficiently processing larger volumes will play a pivotal role in moving the majority of vaccines from clinical trial to full-scale manufacturing."
Dr. Pora demonstrates the higher binding capacity of single-use Mustang membrane capsules for large molecule applications compared to conventional resin- or gel-based column chromatography. The process also incorporates the use of disposable prefilters, sterilizing grade capsules and final filters to provide exponential time, cost and labor savings. She frames Pall's total process management approach in the context of cGMP Annex 13, effective May 2004 in Europe, which specifies additional constraints for the manufacture of clinical grade products.
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.
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.
Dr. Hélène Pora's presentation entitled, "Total Process Management: Technologies for Speeding Up the Development of Viral and Cancer Vaccines," is part of the Innovations For Speedy Manufacturing session, held today at 2:30pm at the Hotel Omni Mont-Royal, Montréal, Canada.