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Pall Ultrafiltration Technology Simplifies Production of Vaccines to Protect Infants and Children from Serious Infectious Diseases

September 23, 2003

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East Hills, NY (September 23, 2003) - - Conjugate vaccines to protect infants and young children from infectious diseases such as meningitis and invasive pneumonia will become more widely available as their long, complicated and expensive production process can be simplified. Ultrafiltration technologies can reduce production time and costs by streamlining many of the 30 or more steps often required to separate and purify conjugate vaccines. This is the focus of a presentation today by Pall Corporation (NYSE: PLL) at BIOPHEX/INTERPHEX California.

Vaccines to prevent serious infectious diseases such as meningitis, invasive pneumonia and ear and blood infections caused by the pneumococcus bacteria are generally less effective in infants and young children, as their immune systems are not mature enough to produce the required antibodies for protection. The development of conjugate vaccines has enabled protection of children at an earlier age against these types of serious infectious diseases. They combine foreign protein and polysaccharides (the cell wall of an infectious bacteria) that help the immature immune system recognize and remember the needed immune response.

Despite the benefits of conjugate vaccines, the complex and expensive manufacturing process has presented a barrier to wider-scale use.

"Pall's innovative purification technologies are used in critical processing steps to manufacture these life-saving vaccines more efficiently and economically," says Ian Sellick, Director of Marketing, Pall Life Sciences. "With the emergence of drug-resistant bacteria and the increasing number of infectious diseases, the need for conjugate vaccines is even more critical."

Purification methods account for as many as half of the production steps to manufacture conjugate vaccines; ranging from the production and purification of polysaccharides, proteins and conjugates, to sterile filtration of the bulk product. Ultrafiltration technology can reduce production time and cost in many of these steps.

Pall's CentrasetteTM ultrafiltration technology provides a more efficient alternative than existing separation methods. A core step during conjugate vaccine production is fractionation, which is used to separate polysaccharides into specific size classes for attachment to proteins. While fractionation is traditionally performed using size exclusion chromatography, ultrafiltration provides a faster, simpler method of capturing specific size polysaccharides. Ultrafiltration also eliminates the need for costly chromatography resins.

Purification of the final conjugate vaccine is another step in the production process. Pall's Mustang® technology, an ion exchange membrane chromatography, provides an efficient polishing step with speed and cost benefits over conventional beaded resin column chromatography.

The pneumococcus bacterium is the leading cause of invasive and noninvasive bacterial infections in the United States. It is responsible for about 3,000 cases of meningitis, 50,000 cases of bacteremia, 500,000 cases of pneumonia and 7 million cases of acute otitis media annually. Although pneumococcal disease affects persons of all ages, infants and children age 5 and younger are especially prone to infection. Each year, about 17,000 cases of invasive pneumococcal disease (e.g. bacteremia, meningitis) occurs in children younger than 5 years, and an estimated 200 children die of the disease. In addition, pneumococcus is the single most common cause of community-acquired pneumonia, sinusitis and acute otitis media in young children.1

Pall Makes Six Presentations at BIOPHEX/INTERPHEX California

In addition to the presentation on purification technology for conjugate vaccine production, Pall has five other presentations at BIOPHEX/INTERPHEX California. These presentations cover new technology to streamline transgenic processing, membrane technology as platform for protein microarrays, use of membrane chromatography and tangential flow filtration in gene therapy for purification of antisense oligonucleotides, new technology for aseptic connections and validating pre-sterilized single use filter capsules.

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