East Hills, NY (April 26, 2005) - - Depth filtration is a mission-critical step to remove impurities from biological solutions in the initial stages of drug and vaccine processing. Conventional single-layer depth filters however are unable to remove the large variety and quantity of impurities found in today's drug applications. The new SUPRAdisc? HP depth filter from Pall Corporation (NYSE: PLL) addresses the need for high performance depth filtration that can remove the widely varying particle sizes inherent in biotechnology and pharmaceutical drug production. Its unique multi-layer filter sheet format enhances manufacturing efficiency and extends service life.
Standard depth filters incorporate a single layer of filter media into a module to capture impurities. The SUPRAdisc HP module incorporates two full-thickness media layers for a higher porosity. As a result, it has greater dirt holding capacities for maximum throughput for biological, bioprocess and pharmaceutical filtration applications. This improves clarification steps, such as whole cell and cell lysate separations, saving time and resources and reducing operating costs.
In some applications the SUPRAdisc HP filter accomplishes cell harvesting in a single processing step, and its performance capabilities decrease the filtration requirements farther downstream in the drug manufacturing process. The modules efficiently use the entire media matrix to offer a longer service life compared to other filters. The technology can also be easily scaled to meet specific manufacturing requirements.
"An increasing number of biopharmaceutical processes contain higher debris loads and a wider distribution of particle sizes than standard depth filtration technology can handle," says Holly Haughney, Ph.D., Vice President, Pall Life Sciences. "The new SUPRAdisc HP filter's robust performance enables greater manufacturing efficiencies, quicker turnaround time and longer service life to satisfy the increasingly complex depth filtration demands of the biotech and pharmaceutical industries."
The SUPRAdisc HP modules are available with a wide range of specific pharmaceutical-grade media that are optimized for different process steps. They remove suspended particles in a wide range of cell culture applications. They ensure high protection for subsequent sterile filters as well as for chromatography columns. The modules are steam sterilizable at 125°C (257°F) for 30 minutes. All plastic components used in construction meet the specification for the biological test listed in the current version of the USP class VI 121°C. Pall SUPRAdisc HP modules and all its components are fully traceable.
Pall Launches Record Number of New Products at Interphex In addition to the new SUPRAdisc HP depth filter, 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 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 latest version of Pall's operating software package that simplifies operation of complex systems. By allowing engineers to make process changes to TFF systems themselves, this software options avoids time-consuming and costly steps associated with reprogramming and revalidation. Its modular design, user-friendly touch screen and pull0down 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 # 4A02.