East Hills, NY (April 26, 2005) - - Pall Corporation (NYSE: PLL) continues to drive wide-scale adoption of disposable processing with the introduction of the first modular TFF System that incorporates single-use components integrated with a mobile cart for downstream processing applications. The new mobile TFF system helps manufacturers realize significant time, cost and safety benefits in biopharmaceutical production.
Disposable technologies are becoming the linchpin of efficient drug production as biotechnology start-ups continue to proliferate and drug manufacturing demand grows. The use of modular, pre-assembled and pre-sterilized disposable systems helps manufacturers minimize the effects of a potential capacity crunch by building efficiency into the production process.
"The new TFF system, the latest addition to our stable of disposable products, brings all the benefits of single-use technologies to downstream processing." says Holly Haughney, Ph.D., Vice President, Pall Life Sciences. "Our breadth of expertise in drug development and production coupled with leadership in development of disposable technologies gives Pall a unique ability to provide complex, single-use systems that give our customers a competitive advantage."
Disposable processing eliminates the need for cleaning and cleaning validation, reduces risks of cross-contamination, operator error and minimizes capital expenditures and space requirements. These benefits multiply as disposable technologies expand from stand-alone devices to multi-component assemblies.
The new TFF system is built with disposable components around a Pall Centrasette?-P polypropylene cassette holder. It is designed for ready installation into process applications ranging from buffer and media filtration to downstream applications, including clarification and downstream processes such as product concentration and diafiltration.
Developed to meet a range of specific process requirements, the fully assembled system integrates disposable STEDIM Flexboy* bags, stainless steel bag support trays, and a tubing assembly. The Pall TFF system is mounted on a mobile cart and incorporates a Pall Kleenpak? capsule for filtration. The benefits of disposable components and a mobile skid combine to offer greater application versatility.
The systems are designed to operate in accordance with FDA cGMP guidelines and regulations, and include stand-alone mobile reservoirs, metering and feed pumps, as well as flow meters and pressure gauges.
Pall Launches Record Number of New Products at Interphex. In addition to the TFF system, Pall Corporation is also introducing four other new products at Interphex 2005. They are:
The new Mustang® XT capsule, an innovative chromatography technology for super-efficient capture of large molecules used to develop DNA and virus-based drugs. This new technology answers the need for greater throughput and superior binding capacity in a wide range of chromatography applications.
The new Kleenpak? connector, a single use device that enables aseptic connections to be made instantly, in just a matter of seconds. Validated to withstand autoclave steam temperatures above 121 degrees Centigrade, it provides process efficiency for an even broader range of applications. It is the only aseptic connection device that does not require laminar flow hoods or other capital equipment to make a connection.
The SUPRAdisc? HP depth filter which enables more efficient cell harvest and clarification steps for drug processing with an expanded range of pharmaceutical grade filtration media. It provides higher dirt holding capacity and longer service life compared to other depth filtration systems.
The latest version of Pall`s operating software that simplifies operation of complex systems. By allowing engineers to make process changes to TFF
systems themselves, this software option avoids time-consuming and costly steps associated with reprogramming and revalidation. Its modular design, user-friendly touch screen and pull-down menu further simplifies control of TFF processes.
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, pharmaceuticals, transfusion medicine, semiconductors, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2004 were $1.8 billion. The Company headquarters are in East Hills, New York with extensive operations throughout the world.
Pall's new products are on display at Booth #1741 at INTERPHEX 2005, Jacob K. Javits Convention Center, New York City, April 26-28, 2005.
Press Conference Luncheon at INTERPHEX 2005 will be held at 12:00 noon on Wednesday, April 27 in room # E18.