Pall Showcases New Technologies at INTERPEX2006 to Address Drug Production Challenges
21 March 2006
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 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
- 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 Worldwide. "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 cycle and 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 through an announcement and special media luncheon on Wednesday, March 22 from 12:30pm-2:00pm 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.
