Pall’s breakthrough in single-use technologies and cutting-edge...

Pall’s breakthrough in single-use technologies and cutting-edge tangential flow filtration

The increasing focus on biotechnology and personalized medicines along with the growth of the vaccine marketplace is changing the face of the biopharmaceutical industry, an $80 billion global market.  Drug manufacturers are challenged by cost pressures, the need for shorter production times and rapid scale-up, as well as bottlenecks in downstream operations. At INTERPHEX2007, Pall Corporation (NYSE:PLL) launches several new technologies to provide the biopharmaceutical industry with tools and systems to more efficiently manage manufacturing processes. A leader in filtration, separation and purification, Pall offers a comprehensive line of integrated solutions for biopharmaceutical manufacturers from upstream to downstream applications.

New Fluid Management Technologies for the Biopharmaceutical Industry

Pall continues to champion the implementation of disposable processing with the launch of its Allegro^TM Systems, an integrated single-use manufacturing solution, and its newest component, the Allegro Biocontainers for collection and transport of process solutions, product intermediates and cell culture media. Single-use technologies, employed by more than 90 percent of biopharmaceutical manufacturers, provide cost, flexibility and quality benefits. They increase efficiency by eliminating the need for cleaning and cleaning validation and reduce cross-contamination risks.

 

Pall Allegro Systems are gamma-irradiated and ready-for-use, facilitating quick start-up and rapid scale-up to help accelerate time-to-market. These qualities are becoming increasingly essential for the production of biotech drugs and vaccines as well as for contract manufacturing organizations.

 

The new Allegro Biocontainers feature a unique combination of design and materials that help manufacturers maximize product recovery and minimize risk of contamination. The comprehensive Allegro Systems portfolio includes disposable filters, tubing and instant aseptic connection devices in addition to the new biocontainers.

 

With the new disposable Kleenpak^TM TFF Microfiltration Capsule, Pall is introducing the industry’s first tangential flow filtration capsule. Tangential flow filtration is used for clarifying, concentrating and purifying proteins. A self-enclosed capsule, the Kleenpak TFF capsule helps improve worker safety by limiting exposure to biologically active solutions. This is an important consideration for manufacturers of vaccines and other potent products that present potential workplace liabilities.

To address the processing bottlenecks caused by higher protein throughput, Pall strengthens its line of ultrafiltration technologies with the introduction of the Omega^TM T-Series Membrane Cassettes.  The new cassettes are constructed with high performance materials that reduce extractables and assure effective mass transfer of proteins to deliver high-purity biological solutions. The advanced filtration performance of the Omega T-Series cassettes is also available in a disposable capsule format through the Minimate^TM  II Capsule. This product easily scales with products in Pall’s extensive line of cassette technologies for truly integrated operations.

New Ultrafiltration Cassettes Enhance High Performance Bioprocessing

The Omega T-Series cassettes incorporate Pall’s high-yield Omega membranes and a new polypropylene screen to increase processing flux rates and product recovery. Materials of construction chosen for the Omega T-Series cassettes ensure a low level of extractables. This reduces the amount of rinsing volumes that are required prior to cassette use, saving time and material costs.

 

The cassettes feature a new exterior design with deeper notches so that cassettes fit more snugly and securely in the holders. The more rigid encapsulation material reduces over-torquing issues that compress membrane channels and impede product flow, which might occur with traditional manual cassette holders.

 

“Our versatile ultrafiltration technologies create value for our customers, especially those faced with the challenge of efficiently purifying recombinant proteins or monoclonal antibodies,” says Thomas Scholz, Marketing Director, TFF Technologies, Pall Life Sciences. “The new Omega T-Series and Minimate II cassettes strengthen our ultrafiltration portfolio and help customers optimize processing performance.”

 

The Omega T-Series cassettes are available in fully scalable formats to facilitate their use in a wide variety of bioprocessing applications. Offered in four sizes, 200 cm², 0.1 m², 0.5 m², and 2.5 m², the cassettes integrate well with most standard stainless steel holders.

For added ultrafiltration versatility, Pall also offers the two smaller sizes of the Omega
T-Series cassettes in the Minimate II single-use format module. Minimate II cassettes are ideal for trials and pilot experiments and can easily scale with Omega T-Series cassettes as they comprise identical materials of construction and flow paths to ensure true linearity in operations. This allows manufacturers to gain critical time-to-market advantages through accelerated scale-up and reduction in the number of trials before full production. Minimate ll cassettes do not require torquing, and as single-use units, these cassettes are easy to use and install, resulting in additional efficiency benefits. 

First Tangential Flow Filtration Capsule for Single-Use Biopharmaceutical Applications

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,” says 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.

 

Integrated Allegro Single-Use Systems with New Disposable Biocontainers for Biopharmaceutical Market

 

Biocontainers are an integral component of single-use processing and are used to collect and transport process solutions, product intermediates and cell culture media.  Pall’s Allegro Biocontainers are manufactured from an advanced film that reduces extractables and leachables to a very low level, and provide broad chemical resistance and an effective oxygen barrier. Its unique design significantly improves the robustness of the system for more efficient drainage and process flow. The new biocontainers easily connect with other Allegro System components including filters, tubing and chromatography devices.

 

“Our new Allegro Biocontainers were specifically developed to address some of the most pressing concerns manufacturers have about expanding implementation of single-use technologies, specifically issues about leachables and extractables and bag handling,” says Helene Pora, Ph.D., Marketing Director, Pall Life Sciences.

 

Single-use systems are becoming the key to efficient bioproduction due to the productivity and quality benefits they offer especially for biotechnology drugs and vaccine producers as well as for contract manufacturing organizations. They eliminate the need for cleaning and cleaning validation and reduce risk of cross-contamination.  Modular, pre-assembled and gamma-irradiated single-use systems also enable quick start-up and/or rapid scale-up, speeding up implementation and time-to-market. These economic and safety advantages multiply as single-use technologies expand from stand-alone devices to multi-component system assemblies.

 

“There is no question that single-use technologies hold the future of biopharmaceutical manufacturing. As a leading provider of disposable technologies, we continue to draw on our technical expertise and thorough process knowledge to develop next generation systems,” says Dr. Pora. “Pall’s decision to invest in designing new, advanced biocontainers is just the latest milestone in our commitment to help customers optimize their processes and better compete in the rapidly changing biopharmaceutical marketplace.”

 

Pall Allegro Systems can be used at all production levels from manufacture of small clinical batches to commercial-scale drug production and can be applied to all biopharmaceutical processes from upstream through downstream and formulation and filling. The Systems are available in customizable configurations adding flexibility to meet varying manufacturing requirements. Manufacturers can easily evaluate different configurations before implementation and should requirements or batch size subsequently change, the system can be easily retailored to meet new needs.

 

Pall Allegro Biocontainers are currently available from 50 milliliters to 50 liters to accommodate various volume requirements. In addition to the new biocontainers, the Pall Allegro Systems incorporate integrated components including Kleenpak™ and Kleenpak Nova capsule filters, a cost-effective alternative to housing and cartridge systems; Kleenpak Aseptic Connectors in a range of sizes that easily snap into place to provide instant sterile connections; Kleenpak Tangential Flow Filtration filter capsules that provide high flux rates with minimal hold-up volumes; and high-capacity, fully scalable Mustang^® membrane chromatography capsules, providing for efficient binding and high flow rates.

Pall subjects the Allegro Systems to best practice validation testing and provides comprehensive documentation to help customers comply with regulatory requirements.

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.