Pall Corp.

May 5, 2005
New Chromatography, Filtration Products Boost Manufacturing Efficiency
At Interphex 2005, Pall Corp. introduced five innovative technologies aimed at increasing drug manufacturing efficiency through customization and disposability. The new technologies deliver a combination of benefits that help drug manufacturers enhance throughput and scalability, eliminate time-consuming steps, shorten processing times and reduce labor. By enabling significant time and cost benefits at multiple points within drug production processes, the new products will help meet the needs of the fast-growing, global biopharmaceuticals industry. The biopharmaceuticals market generated revenues of $45 billion in 2004 and is predicted to reach $98.2 billion by 2011."The nature of the biopharmaceutical industry requires constant innovation to address rapidly changing process needs as new classes of drugs are discovered and developed," says Ken Frank, president of Pall BioPharmaceuticals. "The scope of products we launched at Interphex reinforces our commitment to providing total fluid management across the wide range of biopharmaceutical applications."Super-Efficient Chromatography: The company unveiled an innovative chromatography technology for super-efficient capture of large molecules, especially used to develop DNA and virus-based drugs. The Mustang XT5000 capsule answers the industry's need for greater throughput, superior binding capacity and fast processing in a capsule format for use in a wider range of process chromatography applications.This 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, a growing need with the increasing 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.Single-Use Technologies: Pall also introduced two technologies for disposable processing. The first is a customizable Tangential Flow Filtration (TFF) system that incorporates single-use components for downstream processing applications. The new mobile TFF system can help manufacturers realize significant time, cost and safety benefits in biopharmaceutical production. The second is The Kleenpak Connector, a single-use device that enables aseptic connections to be made in a matter of seconds. Capable of withstanding autoclave steam temperatures up to 130° C, it provides process efficiency for an even broader range of biopharmaceutical applications. It is the only aseptic connector that does not require laminar flow hoods or other capital equipment to make a connection. The disposable device also promotes more efficient manufacturing practices by eliminating the need for cleaning and cleaning validation. High Performance Depth Filtration: Pall's new SUPRAdisc HP depth filter enables more efficient cell harvest and clarification steps for drug processing with an expanded range of pharmaceutical grade filtration media. The SUPRAdisc HP filter offers higher dirt holding capacity and longer service life compared to other depth filtration systems, addressing the industry's needs to remove the widely varying particle sizes inherent in biotechnology and pharmaceutical drug production.Process Simplification: Finally, Pall debuted its latest version of operating software to simplify 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 simplify control of critical biopharmaceutical processes.