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(R) 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 provide a versatile, all-in-one tool to help
process chromatographers 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 http://www.pall.com.
Editor's Notes:
-- The Pall BioSepra(R) PPA and HEA HyperCel(TM) mixed-mode
chromatography sorbents will be introduced at Achema in
Frankfurt, Germany, May 15-19, 2006 in Hall 6, Stand E12-E15.
-- These technologies will also be highlighted at Pall's press
conference at Achema on Wednesday, May 17, at 11.00 a.m. in
Esprit Room in Hall 9.1.
-- Photos and additional information are available at
http://www.pall.com/corporate_39862.asp
