PORT WASHINGTON, N.Y., October 04, 2016 - Pall Corporation, a global leader in filtration, separation and purification, is pleased to announce the launch of breakthrough technologies that for the first time enable integrated, process-scale continuous production of biotherapies in single-use formats. Biopharmaceutical manufacturers are increasingly incorporating continuous technologies to replace traditional batch methods in order to improve consistency, reduce production footprints and shorten lead times. Single-use technologies furthermore improve efficiencies by eliminating cleaning and validation requirements.
“Pall is leading the biopharmaceutical industry forward by making fully continuous, single-use manufacturing possible for process scale applications. Our vision is to enable our customers to scale-up their continuous processing, and with these new technologies we are well on our way of meeting this goal,” says Michael Egholm, Ph.D., VP and General Manager of Biopharmaceuticals at Pall Life Sciences.
CadenceTM BioSMB Process System
As part of Pall’s commitment to streamline purification scale-up from process development (PD) to process scale, Pall’s Cadence BioSMB Process System offers the industry’s first disposable flow path, continuous multi-column chromatography solution. Manufacturers using the Cadence BioSMB PD System can easily scale-up operations to the Cadence BioSMB Process System without changing process parameters, buffers, or sorbents—saving time and money. This technology transforms the entire chromatography process, with smaller column volumes and associated reductions in sorbents and buffer compared to traditional batch systems.
The Cadence BioSMB Process System is designed for continuous purification using feedstreams derived from batch bioreactor volumes of up to 2,000L. The Cadence BioSMB technology reduces costs of chromatographic media by up to 90% without changing sorbents or buffers. The entire single-use flow path of the system can be replaced within 30 minutes, and the valve system does not require cleaning or cleaning validation. More information about the Cadence BioSMB Process System is available here.
Pegasus™ Prime Virus Removal Filters
Pall’s Pegasus Prime virus removal filters deliver consistent, robust virus retention to protect critical biotech manufacturing processes, assure drug quality and safeguard health. The Pegasus Prime family uses a filtration membrane with a unique surface morphology to provide robust capacity and high virus retention. Small scale devices, perfect for preliminary testing, scale-up and virus validation studies remove any virus filtration anxiety with the right format and the desired performance. The process scale filters are water-wet integrity testable and are supplied gamma irradiated to provide high flow and robust capacity, combining process simplification with sustainable process economics at all scales. Pall now has a complete range of virus filters that provide robust virus retention for all monoclonal antibody applications: the Pegasus Prime virus filter for robust virus retention to protect critical manufacturing processes, to the Pegasus SV4 virus filter that combines constant, stable flow rates with high viral clearance for medium to high fouling process fluids More information about Pegasus Prime virus removal filters is available here.
Allegro™ STR Single-Use Bioreactor
To further reinforce its position in upstream manufacturing, Pall has extended its offering of single-use stirred tank bioreactors to now include a 2,000L bioreactor, with working volumes of 400 to 2,000 liters. Pall now has a family of three geometrically similar stirred tank bioreactors, all exceptionally ergonomic and intuitive to handle. Manufacturing, packaging and handling of the single-use biocontainer are designed to ensure its integrity. Supported by extensive long-term life tests, this greatly increases this system’s reliability for large-scale cell culture. Semi-automated biocontainer inflation and deflation procedures speed-up process turnover. In addition, this system’s compact footprint, with a height below three meters, makes it a great fit for most cleanrooms. A direct bottom-driven impellor delivers great power inputs, facilitating a high kLa (up to 40 h-1), and supports good, scalable cell culture performance up to 2,000L. More information about the Allegro STR Single-User Bioreactor is available here.
Pall introduced the novel Cadence Acoustic Separator (CAS) technology* in April 2016 as a robust platform for cell culture clarification without centrifugation. Pall is currently developing a CAS system with a modular design that will enable manufacturers to scale-up clarification operations for a 2,000L bioreactor. The technology is scheduled for launch in 2017. In addition, Pall is developing next-generation CAS technology for continuous perfusion applications. This technology, also due for launch in 2017, is designed to meet biopharmaceutical industry segments that rely on continuous perfusion methods for growing cells.
In addition, Pall will highlight at its booth its next-generation Kleenpak® Presto Sterile Connectors. Made from Bisphenol-A free polyethersulfone, the genderless connectors enable sterile connections in three intuitive, simple steps, even in unclassified environments and without compromising the sterility of the fluid pathways. Kleenpak Presto connectors can be autoclaved or gamma-irradiated. More information about the Kleenpak Presto Sterile Genderless Connector is available here.
Pall’s technologies will be on display at BPI 2016 in Boston, MA from October 4-7 in booth 521. They will be featured among a portfolio of enabling Pall Life Sciences technologies at the booth, and are the subject of many talks during the show. Find the team’s full BPI agenda here.
About Pall Corporation
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide. For more information visit www.pall.com.
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*On June 15, 2015, Pall announced an exclusive licensing agreement with FloDesign Sonics for acoustic wave separation, a disruptive technology for cell culture clarification for both fed-batch and perfusion applications.
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Pall Life Sciences Marketing:
Erin C. Bush
Senior Manager, Global Product Marketing