East Hills, NY (March 21, 2006) - - Testing protein solutions to determine processing conditions for full-scale manufacturing has become very expensive for drug discovery and research laboratories, due to the low available volumes of these solutions in the early stages of the drug life-cycle. To address the critical need for affordable testing equipment that can reliably process small sample volumes, Pall Corporation (NYSE: PLL) has launched two new Tangential Flow Filtration (TFF) systems. The new Minim? II and new Centramate? 500 TFF systems enable laboratories to test ultra-low-solution volumes when determining true scale-up conditions. This optimizes processes and reduces development times. Additionally, the systems provide data-logging to meet increasingly strict regulatory requirements for process design (DQ) validation.
The Minim II system is the industry's first affordable TFF system that performs feasibility and scale-up studies, with data-logging for ultra-low volumes, in a truly reliable and reproducible manner. As an operating system used in conjunction with cassettes, the benchtop Minim II TFF System is applicable to cell and cell lysate clarification, and concentration and diafiltration applications critical to developing countless biotech drug therapies. It can be operated at pressures typically associated with large-scale TFF processes, and offers a completely sanitary design necessary to comply with Good Manufacturing (GMP) standards for calibrated process instrumentation.
The Minim II system's touch-screen operation indicates flow path, pressures and temperatures. It can be used with up to three Minimate? TFF membrane cassettes simultaneously for accurate and quick feasibility and scale-up studies. When using three cassettes of identical molecular weight cut-offs (MWCO), the unit can operate up to 150 square centimeters of effective membrane area, accelerating development times. Cassettes with different MWCOs can also be used simultaneously to select the most appropriate MWCO for a given application. Testing 3 different MWCO membranes in a single experimental run can potentially cut development time for this critical selection process by one-third.
For the next stage in drug development, including pilot scale and early clinical trial process optimization, Pall's new Centramate 500 TFF System enables low-volume testing with minimal rinsing and clean-in-place volumes. The system is ideal for drug discovery applications that are moving to the development cycle, utilizing up to five liter process volumes with the in-built reservoir, and more using external tanks. It provides an effective membrane area ranging from 200 square centimeters up to one square meter.
The Centramate 500 system offers a sanitary design that is self-venting and completely drainable. It is portable with a small footprint and a modular design, and it is suitable for operation in a GMP-qualified environment. In addition to its benefits for drug development, the Centramate 500 system can be used for scale-down applications at the drug manufacturing stage.
The data-logging functions of both the Minim II and Centramate 500 TFF systems allow users to transfer all data as ASCII files, simplifying reporting for regulatory oversight. In light of industry trends towards heightened scrutiny of data used early in the drug development cycle, this provides drug manufacturers with the added benefit of verifiable quality assurance.
"In offering vastly improved functionality, these systems offer a cost-effective solution to laboratories of all sizes," says Thomas Scholz, Marketing Director TFF Technologies, Pall Biopharmaceuticals, Pall Life Sciences. "They also provide a continuum of total fluid management solutions to help drug researchers and manufacturers optimize processes throughout the entire drug development cycle."
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.
The Minim II and Centramate 500 TFF systems 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.