East Hills, NY (March 21, 2006) - - Better process development strategies and scalable technologies are becoming increasingly important as the lines between biotechnology and traditional pharmaceutical companies continue to blur. An increasing number of biotechnology companies are moving beyond discovery to pilot and full-scale drug production. The major pharmaceutical companies continue to increase their investment in R&D for early-stage drug discovery. Moving developments from R&D to full-scale product requires innovative scalable technologies designed for operation under GMP regulations. Pall Corporation (NYSE: PLL) introduces six new technologies at INTERPHEX2006 aimed at helping this converging marketplace bridge the gap between R&D and full-scale production.
These technologies, which cover the range of biopharmaceutical applications throughout each stage of the development and production process, are:
the first fully contained filtration system for safe handling of potent pharmaceutical compounds,
two advanced hybrid sterilizing grade filters that speed downstream processing for emerging therapies based on high protein concentrations,
a new hydraulic chromatography column that automates maintenance and improves safety during drug purification, and
two new systems for process optimization with automated data-logging using small protein volumes.
"By providing total fluid management solutions, these new technologies will help drug companies improve the speed, safety and efficiency of the entire development and production process," says Ken Frank, President, Pall BioPharmaceuticals Global. "Whether protecting workers during active pharmaceutical ingredient (API) production, removing inefficiencies in downstream processing, or improving the cost-effectiveness of process modeling, Pall's new technologies overcome today's broader processing challenges."
New Product Highlights While biotech companies have made significant advances in upstream processes that produce high protein concentrations, they are running into bottlenecks downstream because standard filtration technologies do not perform economically at high flow rates in these high titer solutions. The new Supor® UEKV and Fluorodyne® EX High Flow Sterilizing Grade Cartridge Filters overcome this challenge by delivering exceptionally high throughput to speed production and accelerate time-to-market of new generations of protein-based drugs.
Pall is also announcing new innovations in the chromatography market. Traditional column chromatography systems used to purify biopharmaceuticals require significant downtime and labor to disassemble components for routine maintenance, resulting in lost throughput. In providing an innovative hydraulic lifting mechanism for automatic column disassembly, the new Pall Resolute® DAP column chromatography system cuts routine maintenance time by as much as two-thirds. It significantly streamlines cleaning and improves operational safety, giving manufacturers a flexible solution for multi-use operations such as those found in contract drug manufacturing, where quick and safe maintenance between drug batch processing is essential.
Pall addresses the critical need for affordable testing equipment that can reliably process small sample volumes with the introduction of the new Minim? II and Centramate? 500 Tangential Flow Filtration (TFF) systems. The Minim II system enables laboratories to test solutions at ultra-low-volumes to determine true scale-up conditions, a process which could otherwise consume large volumes of precious new drug material during drug discovery and research. The Centramate 500 system moves this concept up to the next scale, being ideal for drug discovery applications that are further along in the development cycleand available in process volumes up to five liters. Both systems facilitate process optimization and reduced development times. The systems also provide automated data-logging to meet increasingly stringent regulatory requirements.
The need for protection against harmful, biologically active, contaminating particulates and catalysts is growing as new and more potent active pharmaceutical ingredients (APIs), such as cytotoxic (cell killing) drugs to treat cancer, are used during pharmaceutical purification processes. To help protect workers and the surrounding environment from exposure to these hazardous compounds, Pall is introducing the GBK Containment System, the pharmaceutical industry's first all-in-one contained glove bag system that seals securely to a filter housing.
Pall is also promoting the expansion of its operations in Asia at a special media luncheon on Wednesday, March 22 from 12:30p.m.-2:00 p.m. in Room 1E02 at INTERPHEX2006.
"Our expanding technical and geographic capabilities reflect the company's commitment to helping customers around the world optimize drug development and production throughout the entire journey to commercialization," adds Frank.
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.
Forward-Looking Statement This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at www.sec.gov.
These technologies will be on display 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.