East Hills, NY (April 26, 2006) - - Cell separation and protein purification sequences in the laboratory are critical components of process development for new therapies requiring multiple steps that are often labor-intensive and time-consuming. Pall Corporation (NYSE: PLL) is introducing a new bench-top system that automates the process, significantly improving laboratory efficiency and cutting down drug development time by weeks or even months. The new PKL Chromatography System automates laboratory chromatography, the scientific methodology of separating biologics, enabling operations on a 24-hour continuous basis. This flexible laboratory tool performs process optimization for new drugs used in clinical trials and small-scale production. In addition to improving productivity, it also provides a roadmap for easy drug production scale-up.
The PKL Chromatography system permits rapid method and process development for a range of therapeutic source materials, including proteins, peptides, plasmids, and viruses, that are used to produce new drugs. The compact bench-top unit controls flow rates, pressure and time sequences, and automates multiple process optimization steps including equilibration, loading, washing, elution and regeneration. The system also logs and displays critical data in real time, automating batch record-keeping in accordance with regulatory protocols and Good Manufacturing Practices (GMP).
The PKL system handles a large flow range to accommodate several chromatography formats, including conventional column, expanded bed and membrane chromatography. This flexibility is important as membrane chromatography becomes more popular for processing protein, virus and plasmid-based drugs due to its high capacity and flow rates.
The system configuration enables users to install Minimate? (PKL6) or Centramate? (PKL60) TFF cassettes in one of the column positions. Product diafiltration or concentration can be carried out until pre-set parameters have been obtained before column application.
The PKL system is supported by an intuitive and graphic Windows-based software that is user-friendly and facilitates training. Users can view chromatography steps in real time, and a software wizard provides an easy-to-use system for method scouting and process development. Optimized methods at the bench can be easily transferred to process-scale chromatography systems.
"This is a true productivity tool for process development and optimization, helping drug companies move rapidly from bench to production," says Paul Liu, Ph.D., Technical Director, BioPharmaceuticals, Pall Life Sciences. "There are other automated systems out there, but this one performs complex functions and yet is flexible and easy to use."
The PKL chromatography system is available in two sizes. The PKL 6 system handles flow rates from one to 100 mL per minute. The PKL 60 system handles flow rates of 10 to 1,000 mL per minute. Chromatography operations can be scaled up to Pall's PK series of systems that automate chromatographic operations from pilot scale through full-scale production, handling volumes ranging from 10 to 4,000 liters per hour. These systems all enable manufacturers to automate critical chromatographic processes in accordance with cGAMP guidelines. Pall's PK series products support ion exchange, affinity, hydrophobic and gel permeation chromatography applications.
"The PKL system provides a new gateway from the lab to the production floor, enabling manufacturers to bring novel therapies to market more quickly," says Ken Frank, President of Pall BioPharmaceuticals. "This product represents an important new addition to Pall's extensive chromatography portfolio, and it illustrates Pall's commitment to its customers as a total process solutions provider."
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 PKL Chromatography System will be on display at Biotech & Pharm China, Shanghai, April 26-28, 2006, Booth # A01-A06.