Pall Launches Industry's First Single-Pass TFF System for Biopharmaceutical Processing
Breakthrough technology eliminates the recirculation loop to reduce in-process volumes and increase final product concentration, both at high yield
PORT WASHINGTON, N.Y., April 20, 2010 - As biopharmaceutical manufacturers are challenged to improve profits, process developers are searching for new tools to deliver efficiencies and improve economics. To help meet these demands, Pall Corporation (NYSE: PLL) today launched CadenceTM systems, the industry's first single-pass tangential flow filtration (TFF) product designed to optimize downstream purification steps in either single-use or re-use modes of operation. Cadence TFF systems harness a new TFF format, the Cadence module, which incorporates a patented fluid path design that enables direct flow operation with a substantial reduction in system hold-up volume. This, along with improved recovery capabilities, increases yield and achieves high product recovery greater than 98 percent.
Cadence single-pass TFF systems do not use a conventional recirculation loop, allowing them to be coupled with other process steps and thereby increase manufacturing throughput. The system design also eliminates or reduces intermediate storage tanks and associated cleaning when using the systems for in-process volume reduction before or after existing steps. Cadence single-pass TFF systems can be easily integrated with other downstream processes such as chromatography or virus removal.
The unique design of the Cadence modules enables high concentration factors of greater than 20. Cadence modules are comprised of multiple TFF cassettes in series,which results in high conversions of feed-to-permeate in one flow path. This is accomplished by optimizing the module configuration based on cassette performance for a particular application.
The compact design of Cadence systems requires less space in the laboratory, pilot or production area. The recirculation loop is eliminated, and the systems require less pump capacity due to lower flow rates. The smaller pipes and lower working volumes translate to a significantly smaller footprint than any traditional TFF system. The single pass at lower flow rates also results in reduced shear exposure for the processed product.
The unique features of Cadence systems and self-contained modules make them ideal for a range of biopharmaceutical applications, including in-line volume reduction before or after downstream purification steps; desalting protein solutions between chromatography steps; concentrating to high levels for formulation; and processing delicate, aggregation-prone biomolecules.
"At Pall, we strive to address our customers' toughest process challenges. Reducing process time and space, and increasing scale-up flexibility are at the center of every system solution we design," said Zock Zamaniyan, vice president of marketing and global product management with Pall Life Sciences biopharmaceutical division. "By eliminating the recirculation loop of a typical TFF setup, we are helping customers create opportunity for highly efficient TFF in single-use or re-use mode. Based on customer feedback, we focused system developments on simple, economical solutions that address time, space and flexibility. The result is the first true TFF innovation in decades.
"We believe Cadence systems will open up opportunities for researchers and manufacturers to explore new purification schemes and even re-think applications where the final product yield is sensitive to typical TFF conditions. Now, even the most difficult-to-filter materials are in play."
Cadence modules incorporate Pall's proven T-Series cassettes with Delta membrane, which features high flux, high selectivity and low protein binding characteristics. Cadence system volume capacities range from several liters to thousands of liters.
Three module configurations are available, and they are supplied preassembled. The modules' feed, retentate and permeate ports are easily connected to clearly marked system ports for plug-and-play installation.
Cadence single-pass TFF systems are available through Pall Life Sciences and can be ordered by phone at 800-717-7255 in the U.S. or +41 (0)26 350 53 00 in Europe. For a complete listing of international offices, visit Pall online at www.pall.com/contact.
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. Pall technologies are also used to collect and process blood components and help protect patients from hospital-acquired infections. The company's membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics and proteomics markets. Pall is a leading provider of separation systems, and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer, and require less energy and water to produce.
About Pall Corporation
Pall Corporation (NYSE: PLL) is a filtration, separation and purification leader providing Total Fluid ManagementSM solutions to meet the critical needs of customers in biopharmaceutical; hospital, transfusion and veterinary medicine; energy and alternative energy; electronics; municipal and industrial water; aerospace; transportation and broad industrial markets. Together with our customers, we foster health, safety and environmentally responsible technologies. The company's engineered solutions enable process and product innovation and minimize emissions and waste. Pall Corporation, with total revenues of $2.3 billion for fiscal 2009, is an S&P 500 company with more than 10,000 employees servicing customers worldwide. Pall has been named a top "green company" by Newsweek magazine. To see how Pall is helping enable a greener and more sustainable future, visit www.pall.com.