East Hills, NY (April 26, 2005) - - New methods of chromatography are necessary to meet increasing capacity demands and the unique downstream processing requirements of developing and producing drugs. Pall Corporation (NYSE: PLL) answers this growing need with the new Mustang® XT5000 capsule, which provides greater throughput, superior binding capacity, and fast processing in a capsule format for use in a wider range of process chromatography applications.
The next-generation ion exchange membrane capsule extends Mustang chromatography's uses beyond removal of contaminants such as DNA, viruses, endotoxins and host cell proteins. It enables super-efficient capture of large molecules, especially important for the development of new drugs and therapies that utilize recombinant proteins, plasmids and other viral vectors, and blood plasma fractions. With the ability to process large fluid volumes 30 times faster than traditional chromatography resins during capture and polishing steps, the new capsule brings the benefits of Mustang technology to both ends of the process chromatography spectrum.
The 5 Liter Mustang XT5000 offers unprecedented time and cost savings as a function of its single-use format, high volumetric throughput, and ability to efficiently process large molecules. It is the largest chromatography capsule available for reliable process performance. As a single-use capsule, the Mustang XT5000 does not require media packing, cleaning or cleaning validation and precludes the need for cleaning buffers and costly resin. It also prevents cross-contamination risks. As an integral part of Pall's extensive portfolio of single-use technologies, the new Mustang capsule brings manufacturers one step closer to realizing completely disposable manufacturing processes.
"Mustang technology will play a critical role in preventing bottlenecks in process chromatography steps as macromolecule drugs move from clinical trial to pilot and full-scale production," said Holly Haughney Ph.D., Vice President, Pall Life Sciences. "The newest Mustang capsule extends disposability into new processing areas that traditionally use conventional columns. Many downstream processes, including chromatography, have been identified as sources of inefficiency in drug manufacturing. Mustang technology overcomes these inefficiencies by increasing throughput, decreasing labor and processing steps, and reducing contamination risks."
The Mustang XT5000 capsule uses Pall's ion exchange membrane technology to offer exceptional flow rates and high dynamic binding capacity. Mustang chromatography allows biomolecules to access all binding sites by direct fluid convection. Since the binding is not diffusion limited, high dynamic binding and sharp breakthrough curves are achieved over a very wide range of flow rates and a large range of molecular sizes. This results in significant advantages over resins packed in columns, especially where high flow rates may be used and also where large molecules are to be captured or removed.
The Mustang XT5000 capsule demonstrates good resolution, while providing high yields and minimal elution volumes in capture applications as a result of its uniform flow path and very low total volume to membrane volume ratio. Mustang XT5000 systems can be configured in a series or manifolded in parallel for even higher throughput in large volume applications. Installation space is low due to the packing density of the membrane in the capsule and the ability to stack capsules.
To further simplify validation and process development for the Mustang XT5000 capsule, Pall is also introducing the Mustang XT5 capsule, a complementary scale-down unit, which requires small fluid volumes for production support studies. The XT5 capsule has been designed to give a direct scale up to the XT5000 and uses the same materials of construction.
Pall Launches Record Number of New Products at Interphex In addition to the Mustang XT5000 capsule, Pall Corporation is also introducing four other new products at Interphex 2005. They are:
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 up to 130 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 first customizable TFF (tangential flow filtration) system that incorporates single-use components for downstream processing applications. The new mobile TFF system will help manufacturers realize significant time, cost and safety benefits in biopharm production.
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.
Mustang XT5000 capsules will be the focus of a press conference luncheon at Interphex 2005 on Wednesday, April 27 at 12:00 noon in room # E18.