Chromatography Sorbents enable efficient drug manufacturing.

Press Release Summary:



To help overcome production bottlenecks caused by capacity and production purification problems as well as demand for protein-based drugs, BioSepra® PPA and HEA HyperCel(TM) mixed-mode sorbents offer chemistries and separation options for purifying proteins. Environmentally friendly products do not require lyotropic or other salt additives. Ranging from orthogonal to other chromatography steps, additional selectivity options for protein capture or fractionation are provided.



Original Press Release:



New Environmentally Friendly Chromatography Sorbents from Pall Improve Efficiency and Economics of Drug Manufacturing



East Hills, NY (May 15, 2006) - - More than 50 percent of biopharmaceutical companies are adversely affected by manufacturing bottlenecks due to capacity and production purification problems. Compounding this challenge is the increasingly global demand for new protein-based drugs. To help overcome these production bottlenecks, Pall Corporation (NYSE: PLL) is launching two new chromatography sorbents that provide a novel approach to protein purification.

The Pall BioSepra® PPA and HEA HyperCel(TM) mixed-mode sorbents equip process chromatographers with entirely new chemistries and new separation options for purifying proteins for higher yield and recovery under selected conditions. These environmentally friendly sorbents do not require lyotropic or other salt additives, thereby reducing harmful processing conditions that can lead to protein aggregation and impact stability. This contributes to cost savings by reducing and/or eliminating the expenses associated with salt recycling and waste disposal.

The HEA and PPA HyperCel sorbents provide process chromatographers with additional selectivity options (ranging from orthogonal to other chromatography steps) for protein capture or fractionation. Each sorbent combines the characteristics of two chromatography methods of separation - principally hydrophobic interaction chromatography (HIC) and additional ion exchange interactions (IEX). The mixed-mode sorbents can distinguish proteins that have similar or very close isoelectric points, a separation that cannot be achieved with a single ion exchange step. Furthermore, the HIC interaction is achieved at considerably less salt concentrations than that required with traditional HIC.

Unlike conventional HIC methods, the new Pall sorbents do not require the addition of lyotropic salts, such as sodium sulfate or ammonium sulfate, for binding and elution. The ability to bind under neutral "physiological-like" conditions minimizes the risk of protein precipitation and contributes to better protein recovery. Even small reductions in the amount of salt used during purification can significantly decrease cost, especially at commercial production scale. For example, PPA and HEA HyperCel facilitate binding from feedstock or intermediate-stage product pools that cannot be directly applied to traditional ion exchange or HIC sorbents, while also avoiding expensive and environmentally unfriendly salt recycling.

"As the first mixed-mode sorbents of this kind, HEA HyperCel and PPA HyperCel are poised to transform the way process chromatographers purify proteins," says Ken Frank, President of Pall BioPharmaceuticals. "The new sorbents are our latest addition to a continuum of chromatography media based on a proven bead matrix, and offer a broad range of benefits in terms of protein recovery, environmental impact, economics and universal application."

The ability to adjust selectivity for different proteins enables the sorbents to be used in a wide range of applications, including monoclonal antibodies (MAbs), enzymes, vaccines, recombinant proteins and plasma fractions. They can also be easily packed and unpacked in columns, and can be operated at flow rates up to 1,000 cm per hour with low backpressure (typically less than one bar with a 20 cm bed height).

"These new sorbents are like a Swiss army knife for process chromatographers as they provide a versatile, all-in-one tool to help select and fine-tune the optimum separation conditions to capture a target protein or resolve impurities," says Dr. Sylvio Bengio, Scientific Communications Manager, Pall BioPharmaceuticals.

Proteomic applications are a significant driving force in the fast growing chromatography market. Chromatography is one of the most efficient, versatile and viable methods in the biopharmaceutical industry for both laboratory and production scale separation and purification.

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 www.pall.com.

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