Pall Life Sciences Extends the Range of Continuous, Single-Use Technologies To Improve Speed and Quality of Biopharmaceutical Production

PORT WASHINGTON, N.Y.–(BUSINESS WIRE)– 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.

Cadence^TM 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.

What’s Next

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.

Or follow us on social media:

Google+
YouTube
LinkedIn
Twitter
Facebook

^*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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161004005978/en/