Processing Cord Blood
With the
SynGenX™-1000 System
üAdvanced
ü
Technology for Cell Separation and
Cryopreservation
ü
üHigh
CD34, TNC , MNC Recovery and Post
Thaw Viability
ü
üCritical
Process Control with Electronic
Records
ü
üEasy
to Use for Both Small and Large Scale
Operations
Introduction
The SynGenX™-1000 System rapidly separates
stem and progenitor cells from cord blood, and
delivers them into a freezing bag for storage.
Designed to be used with a programmable benchtop centrifuge, the SynGenX-1000 System processes
up to 4 cord blood units at a time in 30 minutes. The
System’s firmware and software provide a printout
of the process and communicate with your host
personal computer for cGMP-compliant medical
record integration.
The components of the System are the SynGenX-1000
Disposable Cartridge, Control Module, Docking
Station, CryoPRO-2 Cryopreservation Storage Bag
Set, CryoPRO Workstation, and DataTrak Software.
The System is available for sale in the U.S. and EU/
EEA.
The Components
The Disposable Cartridge
The SynGenX-1000 Disposable Cartridge processes one unit of cord blood with a volume between
40 and 220 mL. The cord blood unit is sterile-docked with and transferred to the SynGenX™-1000
Disposable Cartridge through a 150 micron pore size clot filter to remove any clots due to
inadequate mixing at collection.
The cartridge is then snapped into
the SynGenX™-1000 Control Module
and placed in the centrifuge with
other cartridges or appropriate
counterweights for balance. During
centrifugation, the blood is separated
into three fractions: red blood cells,
buffy coat, and plasma. The bulk of
the red blood cells are transferred
to the red blood cell compartment.
The buffy coat, containing virtually
all of the stem and progenitor cells,
is automatically transferred into the
harvest compartment in a precise final
volume of 20 ± 0.2 mL. The plasma is
retained in the main compartment and
may be sampled to meet bacteriological
testing requirements.
P: +1 (916) 706-0923
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Control Module
The SynGenX™-1000 Control Module automatically
directs the separation of the three fractions in the
Disposable Cartridge while they are spinning in
the centrifuge. It does so by using an internal
microprocessor, four optical sensors to detect the
interface between the red blood cells and buffy coat,
and accelerometers to monitor the centrifuge speed
and to open and close the tubing in the Disposable
Cartridge, directing the red blood cells and buffy
coat to their respective compartments. It also gathers
and stores information during each centrifuge run
to provide a printout of the centrifuge cycle, and can
download that data to the docking station.
Docking Station
The SynGenX™-1000 Docking Station (DS)
transfers the data collected during the centrifuge
run by the Control Module to the host PC. It also
charges the lithium ion battery of the Control
Module for up to 8 days of operation.
The CryoPRO Workstation and
CryoPRO-2 Cryopreservation/Storage Bag
Set
The CryoPRO Workstation, in combination with the CryoPRO-2 Cryopreservation/Storage Bag Set,
assures consistency and reproducibility of the cryoprotection process, delivers the cryoprotected
cord blood into a newly-designed freezing bag, and documents the cryoprotection process as
noted above. The Workstation controls the stages of the cryopreservation process, including:
• Transfer of the buffy coat from the
SynGenX-1000 Disposable Cartridge to the
mixing chamber of the Set.
• Collection of a blood sample into
a sample bulb for cell count prior to
cryoprotectant addition.
• Precise control of the temperature
of the buffy coat during the addition of
cryoprotectant.
• Precise control of the flow rate of the
cryoprotectant solution, using a built-in
syringe pump.
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Email: sales@syngeninc.com
• Air-free filling of the freezing bag, using an
air displacement device.
• Transfer of the cryoprotected buffy coat to the
freezing bag.
• Confirmation of the fit of the freezing bag into
the storage cassette.
The CryoPRO-2 Set incorporates a new freezing
bag design that eliminates the need for heatsealing between large and small chambers, while
allowing easy separation of those chambers if
desired.
DataTrak Software
The SynGen™ DataTrak (DT) software is installed on the host PC and is the user interface for
the SynGenX-1000 System. It downloads data from the Control Module, including the timing
and duration of the opening and closing of the red blood cell and buffy coat transfer tubes, and
documents the successful completion of the processing cycle. The software also collects data from
the CryoPRO Workstation, including the temperature of the buffy coat during the introduction of
the cryoprotectant and the duration of delivery. This data documents each cord blood processing
run to support cGMP compliance.
P: +1 (916) 706-0923
F: +1 (916) 706-0832
Ancillary Equipment to Enhance Workflow
The Sterile Docking Workstation
The Sterile Docking Workstation provides
a labor saving means of sterile docking
the cord blood collection bag to the
SynGenX™-1000 Disposable Cartridge and,
later in the process, the buffy coat harvest
tubing of the Disposable Cartridge to the
CryoPRO-2
Cryopreservation/Storage
Bag Set. The Sterile Docking Workstation
optimizes the lengths of the docked tubing.
The 4-station tray provides a convenient
way to move up to 4 disposable cartridges
between workstations and the centrifuge to
improve workflow.
The Disposable Cartridge Transfer Workstation
If the user processes with HES, the Disposable
Cartridge Transfer Workstation automates the
addition of HES through a 0.2 micron filter into
each of 4 cord blood units at a time.
The
SynGenX-1000
System:
Processing Cord Blood
The SynGenX-1000 system provides you with
a single system that can be used to process cord
blood from the blood bag to the freezer for storage.
Up to four cord blood samples can be processed
simultaneously, with data recorded regarding the
separation and collection of the plasma, red blood
cells and buffy coat, and the addition of DMSO
for cryopreservation. The following flow diagram
goes through the steps that enable you to go
through processing, harvesting, and preserving
the valuable cord blood units - providing high
yields of viable cells.
Web: www.syngeninc.com
Email: sales@syngeninc.com
P: +1 (916) 706-0923
F: +1 (916) 706-0832
Web: www.syngeninc.com
Email: sales@syngeninc.com
M0002-A
The SynGenX-1000 - A Complete System Solution
Blood Processing
for
Cord
The SynGenX-1000 provides rapid, sterile processing of cord blood from arrival at the center
to final storage in a newly-designed freezer bag. In addition, the system provides data
confirmation of the processing steps.
Features of the SynGenX-1000 System:
»» Reliable isolation of cord blood into three components: a buffy coat (containing stem
and progenitor cells) red blood cells, and plasma.
»» Processing of cord blood volumes between 40 mL and 220 mL, with a consistent buffy
coat harvest volume of 20 ± 0.2 mL and a hematocrit of 24 ± 2%.
»» Processing of up to 4 cord blood units in a single centrifuge run.
»» Easy sterile pre- and post-processing sample collection using needle-less sampling
pouches.
»» Protection from inadvertent clots during processing with the built-in 150 μm clot filter .
»» Protection from inadvertent contamination with an integrated 0.2 micron filter port for
HES addition and an integrated 0.2 micron filter in the cryopreservation line.
»» New freezing bag design to eliminate the need for heat-sealing between large and small
chambers, yet allowing easy separation of those chambers if desired.
For information on how the SynGenX-1000 System can optimize your cord
blood processing, please contact sales@syngeninc.com or call us at +1 (916)
706-0923.
Syngen, Inc.
Web: www.syngeninc.com
Email: sales@syngeninc.com
P: +1 (916) 706-0923
F: +1 (916) 706-0832