Pall Provides Biotech Industry with Its First Single Use Depth Filter for Disposable Drug Processing

03/16/04 -- To meet the growing need for single use technologies for the production of biopharmaceuticals, Pall Corporation (NYSE: PLL - News) 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) 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® EKV 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 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® Flowstar MUX 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 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)

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), PK50 (50-1000 LPH) and PK300 (300-4000 LPH), these advanced control systems enable automated chromatographic 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, semiconductors, municipal drinking water, aerospace and broad industrial markets. Total revenues are $1.6 billion. The Company headquarters are in East Hills, New York with operations in more than 30 countries. Further information is available at www.pall.com.

Source: Pall Corporation