East Hills, NY (March 21, 2006) - - Biotechnology companies are making significant advances in production of higher concentrations of proteins critical to meeting the demand for life-saving therapies. Despite this advance, production bottlenecks remain because standard filtration technologies lack the ability to perform economically at high flow rates in these high concentration solutions. Working to meet the challenge faced by one of the world's leading biotechnology companies, Pall Corporation (NYSE: PLL) developed two new filtration technologies that significantly improve production throughput for protein-based biotech drugs. The new Supor® UEKV and new Fluorodyne® EX high flow sterilizing grade cartridge filters are each unique hybrids that offer the biotech industry cost-effective solutions to processing challenges.
Sterilizing grade filters are utilized throughout the drug processing cycle from initial purification steps to final formulation and filling to remove bacteria and other contaminants. The validated and technologically advanced 0.2 micron sterilizing grade Supor UEKV filter brings together Pall's proprietary Ultipleat® high-efficiency membrane packing technology with a new small-core design that enables a 50 percent increase in filter membrane area in the same size filter element. The Supor UEKV filter also incorporates Pall's innovative machV prefilter membrane layer composed of a polyethersulfone (PES) with a multi-dimensional asymmetric pore structure. This filter construction provides consistent contaminant removal capacities at an exceptionally high processing rate of 17 liters per minute at 100 mbar (12 lpm/psid). This flow rate is approximately 35 percent faster than previous generation filters with conventional pleating and core geometry. The mach V prefilter layer and extra filter membrane area extends the service life of the filter and reduces replacement costs.
Supor UEKV filters are able to clarify and sterilize cell-containing fermenter harvests and tissue culture media faster than conventional membrane cartridge technology and are compatible with fluids across a wide pH range, from buffers to numerous biological fluids. Sturdy construction enables the Supor UEKV filter to tolerate up to one bar (14.5psi) of differential pressure during steam-in-place sterilization, making it highly resistant to steam pressure incursions and the filter is easy to wet for reliable integrity testing.
The new Fluorodyne EX filter is also constructed with Pall's Ultipleat design. It provides an alternative leading-edge hybrid technology by fitting a proprietary built-in mach V PES prefilter membrane layer over a proven high flow 0.2 micron polyvinylidinedifluoride (PVDF) sterilizing membrane. This dual membrane combination also delivers high dirt-holding capacities and high flow rates, as well as the flexibility for steam sterilizing under wet or dry conditions. The ability to steam sterilizing the filters without pre-wetting reduces preparation time, as a separate wetting step is not required.
The Fluorodyne EX filter technology can be used to sterilize a wide range of fluids including buffers, biological fluids, tissue culture media and ophthalmic products. The asymmetric built-in prefilter membrane layer enables the Fluorodyne EX filter to process the heightened levels of contaminants often found in high protein biotech solutions, with low protein and preservative binding, and low extractables.
"The biotech industry relies heavily on sterilizing grade filtration, but until now, process membrane filtration technology has not kept pace with advances further upstream," says Monica Cardona, marketing manager, Western Hemisphere, Pall Life Sciences. "Pall's new sterilizing membrane filtration technologies are the result of close alignment with our biotech customers to help them maximize efficiency downstream, enabling greater throughput of the high concentration biological products common today."
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, pharmaceutical, transfusion medicine, semiconductor, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2005 were $1.9 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. Visit Pall at http://www.pall.com.
Both the Supor® UEKV and Fluorodyne® EX High Flow Sterilizing Grade Cartridge Filters will be on display and at INTERPHEX2006, Jacob K. Javits Convention Center, New York, March 21-23, 2006, Booth # 1825.
During her 16-year tenure with Pall Corporation, Dr. Holly Haughney has held many senior-level positions within the BioPharmaceutical, Food & Beverage, and Scientific and Laboratory Services Departments. Dr. Haughney?s new appointment and relocation to Bangalore, India underscores the growing importance of the Asian market to the Company. In her new role, she manages the BioPharmaceuticals marketing teams throughout Asia, including China, India, Korea, Southeast Asia, Australia, New Zealand, and Taiwan, where she is charged with establishing product positioning and strategy for key market areas: biologicals, biotechnology, vaccines, formulation and fill and APIs. She will coordinate and foster communications within these areas and across the region working with product managers, application managers and the R&D teams. She is also responsible for developing relationships with key universities, regulatory authorities and industry groups in Asia.
Dr. Haughney is the recipient of several honors and fellowships throughout her career, including the American Association of University Women Fellowship in the Selected Professions, Howard Isermann Graduate Fellow in Biochemical Engineering, and the Proctor and Gamble Graduate Achievement Prize. She graduated from Cooper Union with a bachelor's degree in Chemical Engineering. She also received a Ph.D., an M.S. and B.E. in Chemical Engineering from Rensselaer Polytechnic Institute (RPI), New York.
Vinay Joban, General Manager, Pall Life Sciences India
Hazelle Lam is responsible for strategic marketing activities for Pall BioPharmaceuticals? filtration and separation products in the Southeast Asia region, primarily in Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines. Prior to joining Pall, she worked at Bio-Rad Corporation as the Southeast Asian product manager for protein separations and protein function products where she played a major role in supporting its Expression Proteomics platform. Her previous work experience includes six years in sales and marketing with Research Instruments, and two years with Asia Pacific Genomics, both in Singapore.
Ms. Lam received a diploma in biotechnology as well as a graduate diploma in international business from Ngee Ann Polytechnic, Singapore.