East Hills, NY (May 11, 2005) - - As the worldwide demand for protein-based drug therapies increases, manufacturers require new processing technologies to handle capacity challenges efficiently and cost-effectively. Pall Corporation (NYSE: PLL) releases data today demonstrating super-efficient capture of complex proteins with a new technology designed to purify high-volumes of biological solutions used in downstream drug production. The results confirm that its new five-liter Mustang® XT5000 membrane chromatography capsule, the first membrane system for high-volume protein capture, provides an efficient way to expedite processing of a broad range of drugs including viral vaccines and gene therapies. New data on its performance will be presented today at the 18th Annual Preparative/Process Chromatography Exhibit (PREP 2005) in Philadelphia.
The Mustang XT5000 capsule answers the industry's need for greater throughput, superior binding capacity and fast processing in a capsule format. The studies presented today demonstrate that the capsule supports flow rates of at least 50 liters of mobile phase per minute, similar to the performance of a 300-liter chromatography column. Each capsule also shows a protein capacity of approximately 400 g of Bovine Serum Albumin (BSA). Additional tests confirm the purification of a 4.5Kb plasmid from a clarified E. coli lysate, achieving and maintaining a flow rate of 50 L per minute. These studies provide an indication of the technology's ability to process typical feedstocks used in biopharmaceutical production.
Ion exchange membrane chromatography supports the use of exceptionally high flow rates because molecules access all binding sites by direct fluid convection. Since binding is not diffusion limited, high dynamic binding and sharp breakthrough curves are achieved over a wide range of flow rates and molecular sizes. The new Mustang XT5000 capsule can process large fluid volumes 30 times faster than traditional chromatography resins during both capture and polishing steps. This offers significant advantages over resins packed in columns, especially when capturing or removing large molecules or when high flow rates must be achieved. The processing of large molecules is especially critical to the industry with the increasing development of new therapies that use recombinant proteins, plasmids and other viral vectors and blood plasma fractions.
"The data confirms that membrane chromatography can be used for the process scale applications, especially high-volume protein capture, and no longer needs to be limited to final polishing or other low-volume processing steps in drug manufacturing," reports Peter R. Levison, Ph.D., Technology Development Director, Pall Life Sciences.
Drug manufacturers typically use resin-packed stainless steel columns for high-volume capture steps. Column chromatography, however, requires cleaning and cleaning validation, is limited by slow diffusion factors and can be especially costly for scale-up operations. As a single-use technology, the Mustang XT5000 capsule is pre-packed eliminating the need for cleaning and cleaning validation, further reducing manufacturing costs as well as risks of cross-contamination. Its small footprint and compact design enables simple scale-up.
"This new Mustang technology will play a critical role in eliminating bottlenecks in process chromatography during full-scale drug production," Levison says. "It overcomes the challenges inherent in column chromatography by increasing throughput and lowering overall labor and manufacturing costs. It enables drug manufacturers to process large volumes of biological feedstreams quickly, while enjoying the economic benefits of disposable units with a small operating footprint."
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.
Dr. Levison's presentation, entitled "Scale Up of Membrane Chromatography for Process Applications," will be presented in Session 8 ("Applications") at PREP today at 3.20pm at the Loews Hotel, Philadelphia, PA.