Articles

East Hills, NY (September 23, 2003) - As demand for protein-based drugs outpaces manufacturing capacity, biotech and pharmaceutical companies are turning to transgenic sources such as corn, milk and animals to produce the high volumes of biological compounds necessary to treat cancer, diabetes, heart disease, hepatitis and other chronic diseases. A breakthrough separation technology from Pall Corporation (NYSE: PLL) significantly speeds up and improves the ability to manufacture transgenic drugs. The PallSep™ filtration system incorporates vibrating membranes to recover target proteins from transgenic plant and animal-derived materials more efficiently and cost effectively than conventional separation methods.

Materials from transgenic sources are typically difficult to process because they contain a high level of solids. The PallSep filtration system differs from conventional separation technologies by using oscillating vibrations to produce clarified protein extracts from challenging biological fluids. This innovative approach uses less energy and processes biomass more gently for higher transmission and increased yield of target protein molecules.

"The PallSep technology represents a major advance in transgenic drug manufacturing because it streamlines clarification methods," says Ian Sellick, Director of Marketing, Pall Life Sciences. "As a truly enabling technology, it will help biotech manufacturers keep pace with the explosive growth of transgenics."

The ability to produce and recover recombinant proteins by transgenic production offers pharmaceutical manufacturers the potential for a substantially more cost effective and faster drug production method. Transgenic drug technologies involve genetically altering plants and animals to express high levels of complex proteins and other biomolecules which may be used to process therapeutics, vaccines, excipients, diagnostics and nutraceuticals. They can produce higher volumes of biological compounds compared to traditional cell culture methods, improving manufacturing flexibility, lowering production costs and streamlining scale-up.

There are more than 350 protein-based therapeutic candidates currently in clinical and preclinical trials. The total protein manufacturing market is expected to reach over $6.4 billion by 2005.

About PallSep Filtration System
The PallSep filtration system is composed of a sealed stack of flat, circular membrane plates connected by a torsion bar to a seismic mass. A controlled torque is applied to the seismic mass by means of a motor. The motor induces oscillation of the membrane stack at approximately 60Hz, which corresponds to the system's natural resonant frequency. Unlike traditional separation methods that rely on pumping at increased velocity and pressure to handle challenging solutions, the vibrating technology of the PallSep filtration system minimizes pumping, resulting in gentler handling, less heating and a more efficient process.

PallSep units can capture recombinant material from process slurries in a single pass, without the need for process streams to be recirculated. They enable predictable and consistent flux rates to improve and simplify batch processing.

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