East Hills, NY (April 25, 2007) - - Recent advances in fermentation and cell culture technologies have increased protein titers in process fluids, requiring robust and reliable upstream technologies to handle these growing production demands. To enhance efficiency in cell concentration and cell harvesting, Pall Corporation (NYSE:PLL) introduces the industry's first tangential flow filtration capsule. The KleenpakTM TFF Microfiltration Capsule offers a high-flux rate with minimal hold-up volumes even under the most demanding bioprocessing conditions. Biopharmaceutical manufacturers benefit from the unique combination of an efficient microfiltration mechanism packaged in a disposable, easy-to-use capsule.
The Kleenpak TFF MF Capsule is a self-enclosed unit, increasing worker safety by limiting exposure to biologically active solutions. This is a critical consideration for manufacturers of vaccines and other products that present potential workplace hazards. As a disposable unit, the capsule also eliminates the need for cleaning and cleaning validation and reduces risks of cross contamination in multiple-product operations such as contract manufacturing.
Within the compact Kleenpak TFF MF Capsule, Pall's Supor® membrane provides a large surface area for filtration to increase throughput. Constructed of polyethersulfone, the membrane also has exceptionally low adsorption characteristics to enable molecules of interest to pass through, and ensures a high level of product recovery. The capsules are available in three pore ratings (0.65µm, 0.45µm and 0.2µm) to enable their use with a wide variety of biological fluids, including mammalian, yeast and bacterial cells.
The Kleenpak TFF MF Capsule offers a cost-effective alternative to traditional TFF cassettes that require additional operation steps to fasten filter holders onto cassette assemblies. These additional steps require operator skill, and errors such as over-torquing and improperly fastening cassette holders can cause membrane compression, reduce fluid flow and limit processing productivity. In contrast, Pall's completely self-contained and easy-to-use Kleenpak TFF MF Capsule reduces operator error and eliminates lengthy set-up processes. It also decreases capital costs because no stainless steel housings are required.
"The Kleenpak TFF MF system offers a new and exceptionally productive cell harvesting technology that is disposable," say Xuemin Liu, PhD, Marketing Manager, Pall BioPharmaceuticals. "It combines the benefits of a crossflow filtration system and a robust capsule format to minimize product loss, improve worker safety and save manufacturers time and money."
Typical process volumes for this single-use technology are approximately 200L, however capsules can be manifolded easily to accommodate larger process requirements. The Kleenpak TFF MF capsule is manufactured to withstand autoclave sterilization as well as temperature extremes that are possible during storage and transport. It is also highly resistant to a variety of chemicals and is composed of low-extractable materials. The Kleenpak TFF MF Capsule can be easily connected to other components in Pall's Allegro single-use product offering, including tubing, bags and connectors, to form a complete disposable assembly.
About Pall Corporation Pall Corporation is the global leader in the rapidly growing field of filtration, separation and purification. Pall is organized into two businesses: Life Sciences and Industrial. These businesses provide leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, energy, electronics, municipal and industrial water purification, aerospace, transportation and broad industrial markets. Total revenues for fiscal year 2006 were $2.0 billion. The Company headquarters is in East Hills, New York with extensive operations throughout the world. For more information visit Pall at www.pall.com
Pall's Kleenpak? TFF MF Capsules are on display at booth # 1819 at INTERPHEX2007, Jacob K. Javits Convention Center, New York, NY, April 24-26, 2007.