East Hills, NY (April 26, 2005) - - Chromatography and Tangential Flow Filtration (TFF) are critical purification steps widely used to process biotech drugs, including monoclonal antibody-based therapeutics. The latest version of Pall Corporation's (NYSE: PLL) operating software package, simplifies operation of these complex systems. By allowing engineers to make process changes to TFF systems themselves, this software package 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.
The software simplifies scale-up of process control by providing a standard platform for Chromatography and TFF applications from pilot to full-scale production. The software's ability to operate on multiple control platforms also enables process systems to be even more tailored to specific customer needs.
"With manufacturing capacity expected to tighten, drug companies are looking at new ways to improve all aspects of processing, including steps to streamline process control," says Thomas Scholz, Pall Life Sciences. "The user friendliness of the new software provides biopharm manufacturers with greater flexibility and freedom in programming recipes, changing parameters and optimizing their processes without the need for software revalidation, saving both time and money."
An intuitive interface and modular design enables process interaction and optimization in simplified steps, thereby reducing training and labor. As a 21 CFR Part 11-enabling solution, the new process control software ensures the authenticity and integrity of electronic records and associated electronic signatures. It is designed and developed following ISPE GAMP 4 guidelines to assure high quality and well-documented information simplifying the end-user validation.
"Providing scaleable process control technologies is an important part of Pall's total fluid management offering to biopharmaceutical manufacturers as we continue to insure that our customers have the benefits of the most advanced state-of-the-art technologies," Mr. Scholz added.
Pall Launches Record Number of New Products at Interphex In addition to this software, 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 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.
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.