East Hills, NY (April 25, 2007) - - Improvements in product safety, time-to-market and cost savings are driving the increased implementation of single-use technologies by the biopharmaceutical industry. Over 90 percent of pharmaceutical and biotechnology companies currently use disposable technologies in their manufacturing process. Pall Corporation (NYSE:PLL) is introducing the Pall Allegro? Systems, an integrated single-use manufacturing solution to help the biopharmaceutical industry apply disposable technologies to optimize their process efficiency. The Company is also launching the Systems' newest component, Allegro Biocontainers, which feature a unique combination of design and materials that help manufacturers maximize product recovery and minimize risk of contamination. The new Allegro Systems provide the industry with a comprehensive, integrated, disposable system that is manufactured, gamma-irradiated and provided ready-for-use.
Biocontainers are an integral component of single-use processing and are used to collect and transport process solutions, product intermediates and cell culture media. Pall's Allegro Biocontainers are manufactured from an advanced film that reduces extractables and leachables to a very low level, and provide broad chemical resistance and an effective oxygen barrier. Its unique design significantly improves the robustness of the system for more efficient drainage and process flow. The new biocontainers easily connect with other Allegro System components including filters, tubing and chromatography devices.
"Our new Allegro Biocontainers were specifically developed to address some of the most pressing concerns manufacturers have about expanding implementation of single-use technologies, specifically issues about leachables and extractables and bag handling," says Helene Pora, Ph.D., Marketing Director, Pall Life Sciences.
Single-use systems are becoming the key to efficient bioproduction due to the productivity and quality benefits they offer especially for biotechnology drugs and vaccine producers as well as for contract manufacturing organizations. They eliminate the need for cleaning and cleaning validation and reduce risk of cross-contamination. Modular, pre-assembled and gamma-irradiated single-use systems also enable quick start-up and/or rapid scale-up, speeding up implementation and time-to-market. These economic and safety advantages multiply as single-use technologies expand from stand-alone devices to multi-component system assemblies.
"There is no question that single-use technologies hold the future of biopharmaceutical manufacturing. As a leading provider of disposable technologies, we continue to draw on our technical expertise and thorough process knowledge to develop next generation systems," says Dr. Pora. "Pall's decision to invest in designing new, advanced biocontainers is just the latest milestone in our commitment to help customers optimize their processes and better compete in the rapidly changing biopharmaceutical marketplace."
Pall Allegro Systems can be used at all production levels from manufacture of small clinical batches to commercial-scale drug production and can be applied to all biopharmaceutical processes from upstream through downstream and formulation and filling. The Systems are available in customizable configurations adding flexibility to meet varying manufacturing requirements. Manufacturers can easily evaluate different configurations before implementation and should requirements or batch size subsequently change, the system can be easily retailored to meet new needs.
Pall Allegro Biocontainers are currently available from 50 milliliters to 50 liters to accommodate various volume requirements. In addition to the new biocontainers, the Pall Allegro Systems incorporate integrated components including Kleenpak? and Kleenpak Nova capsule filters, a cost-effective alternative to housing and cartridge systems; Kleenpak Aseptic Connectors in a range of sizes that easily snap into place to provide instant sterile connections; Kleenpak Tangential Flow Filtration filter capsules that provide high flux rates with minimal hold-up volumes; and high-capacity, fully scalable Mustang® membrane chromatography capsules, providing for efficient binding and high flow rates.
Pall subjects the Allegro Systems to best practice validation testing and provides comprehensive documentation to help customers comply with regulatory requirements.
About Pall Corporation Pall Corporation is the global leader in the rapidly growing field of filtration, separation and purification. Pall is organized into two businesses: Life Sciences and Industrial. These businesses provide leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, energy, electronics, municipal and industrial water purification, aerospace, transportation and broad industrial markets. Total revenues for fiscal year 2006 were $2.0 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. For more information visit Pall at www.pall.com.
The Pall AllegroTM Systems and Allegro Biocontainers are on display at booth # 1819 at INTERPHEX2007, Jacob K. Javits Convention Center, New York, NY, April 24-26, 2007.