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New Technology from Pall Provides Biotech Industry with Its First Single Use Depth Filter for Disposable Drug Processing; One of Six New Products Pall is Launching at INTERPHEX 2004.


Business Editors/Health/Medical Writers

BIOWIRE2K

Interphex 2004

EAST HILLS, N.Y.--(BUSINESS WIRE)--March 16, 2004

To meet the growing need for single use technologies for the production of biopharmaceuticals, Pall Corporation (NYSE NYSE

See: New York Stock Exchange
: PLL PLL - phase-locked loop ) is introducing the first disposable depth filter capsule for pilot through large-scale biotech drug manufacturing. The SUPRAclean depth filter capsule combines the performance, value and safety of Pall's depth filters into a single use capsule that saves time, labor and operating costs. Depth filters are an invaluable tool for efficient and economical clarification and prefiltration of biological solutions used to manufacture recombinant protein-based drugs, vaccines and blood products. The SUPRAclean depth filter capsule will play a critical role in drug production as biopharmaceutical companies increasingly adopt disposable processing solutions to reduce validation bottlenecks, contamination risks and cost.

"The SUPRAclean capsule is the latest addition to our growing portfolio of single use solutions for biopharmaceutical manufacturing and will further drive our business through recurring sales," said Ed Hoare, President of Pall BioPharmaceuticals. "Disposable products help the industry bring new drugs to market faster, prevent costly setbacks in commercial production and also reduce capital costs in new plant designs."

The increasing number of biotechnology products moving from clinical trial into full-scale production continues to drive the need for new manufacturing facilities where the use of disposable products is rapidly becoming the method of choice. The Supraclean depth filter capsule gives manufacturers a host of benefits that only a single use system can provide. It eliminates the costs associated with the Cleaning-in-Place (CIP (1) (Common Isochronous Packet) The packet format used in time-based (real time) FireWire transmission. See FireWire, IEC 61883 and mLAN.

(2) (Common Industrial P
) cycle. This includes cleaning of the housing, which can cause production bottlenecks and add cost, and cleaning validation, which can delay commercialization of new drugs.

Its design increases safety by significantly decreasing operator exposure to the product. The capsule design also provides a lower hold-up volume than standard module housings, allowing for greater recovery of the product. The housing, which functions primarily as a means of secondary containment, is cleanable, improves sealing and promotes uniform flow distribution. Its ease of installation also decreases the time and labor required for this process.

The SUPRAclean depth filter capsule can be used with Pall's full range of depth filter modules.

Pall Launches Diverse Range of Technologies at INTERPHEX

In addition to the SUPRAclean capsule, Pall is launching five other new products to improve efficiency and quality of biopharmaceutical manufacturing.

The new Supor(R) EKV EKV Exoatmospheric Kill Vehicle
EKV Erythrokeratodermia Variabilis
EKV Enz-Krummenacher-Vittoz (model) 
 0.2 micron sterilizing grade filter with machV membrane technology removes contaminants from buffer solutions, tissue culture media and other process fluids used in drug manufacturing. Utilizing a proprietary funnel-shaped pore design, the Supor EKV filter significantly improves flow rate, by as much as 50 percent, to significantly shorten production cycles.

Also to facilitate the growing use of disposable components, Pall is launching its disposable manifolded filtration systems. Disposable filter capsules can be pre-bundled as a fully integrated pre-sterilized single use filtration system. The pre-assembled systems are customized to include a variety of sterilized ster·il·ize  
tr.v. ster·il·ized, ster·il·iz·ing, ster·il·iz·es
1. To make free from live bacteria or other microorganisms.

2.
 manifolded options combining several filtration steps to meet a wide range of processing needs. The "plug and play" right out of the box system saves process times and labor costs and eliminates cleaning while also minimizing cleaning validation requirements.

The Palltronic(R) Flowstar MUX (MUltipleXor) See multiplexor.

mux - multiplexing
 filter integrity test system enables testing of multiple discrete filters in a single set up to save operator time and to increase the reliability of test results. The new system can integrity test up to eight filters sequentially in any combination of filter size and test type. Its internal memory capacity is able to save a full electronic audit trail of test results, programs, user information and system settings, for a high degree of insurance in both data integrity and traceability.

Pall's multi-cartridge Advanta(TM) stainless steel stainless steel: see steel.
stainless steel

Any of a family of alloy steels usually containing 10–30% chromium. The presence of chromium, together with low carbon content, gives remarkable resistance to corrosion and heat.
 filter housings provide large-scale biopharmaceutical drug manufacturers with a flexible housing design that enables Clean-In-Place operation. The new Pall Advanta housings were specifically developed for large-scale liquid filtrations where multiple numbers of cartridges are used. It is among the first in the industry to meet the American Society for Mechanical Engineers (ASME ASME - American Society of Mechanical Engineers ) standards for a fully drainable design.

Pall is also launching its new PK series chromatography control systems at Interphex. Available in three sizes: PK10 (10-100 LPH LPH LED (Light Emitting Diode) Print Head
LPH Amphibious Assault Ship (Helicopter)
LPH Liters Per Hour
LPH Landing Platform/Helicopter
LPH Ley de Propiedad Horizontal
LPH Left Posterior Hemiblock
), PK50 (50-1000 LPH) and PK300 (300-4000 LPH), these advanced control systems enable automated chromatographic chro·mat·o·graph  
n.
An instrument that produces a chromatogram.

tr.v. chro·mat·o·graphed, chro·mat·o·graph·ing, chro·mat·o·graphs
To separate and analyze by chromatography.
 operation from pilot scale through full-scale productions. The PK series products deliver precision in-line dilution and fast and accurate step or linear gradients. Featuring a fully drainable design and low hold up volumes, they are fully equipped for efficient Clean-in-Place (CIP) operations.

About Pall Corporation

Pall Corporation is the leader in the rapidly growing fields 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, pharmaceuticals, transfusion medicine transfusion medicine Blood banking A subspecialty of clinical pathology or internal medicine which is involved in Pt management through administration of blood cells and blood products including fresh-frozen plasma and cryoprecipitate; TM specialists are versant in , semiconductors, municipal drinking water drinking water

supply of water available to animals for drinking supplied via nipples, in troughs, dams, ponds and larger natural water sources; an insufficient supply leads to dehydration; it can be the source of infection, e.g. leptospirosis, salmonellosis, or of poisoning, e.g.
, aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842.  with operations in more than 30 countries. Further information is available at www.pall.com.

Editors' Note:

These new technologies are on demonstration at Pall's booth #1321 at INTERPHEX 2004, Jacob K. Javits Convention Center Jacob K. Javits Convention Center is a large convention center on the west side of Manhattan in New York City. It was designed by architects I. M. Pei and partners. The revolutionary space frame structure was built in 1986 and named for New York Senator Jacob K.  in New York City New York City: see New York, city.
New York City

City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S.
, March 16-18, 2004.

Pall executives are available for interviews.

Photos of these five new technologies can be found on www.pall.com/pressroom
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 16, 2004
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