Processing Cord Blood With the SynGenX System

Size: px

Start display at page:

Download "Processing Cord Blood With the SynGenX -1000 System"

Molly Harrell
8 years ago
Views:

1 Processing Cord Blood With the SynGenX System üadvanced ü Technology for Cell Separation and Cryopreservation ühigh ü CD34, TNC, MNC Recovery and Post Thaw Viability ücritical ü Process Control with Electronic Records ü üeasy to Use for Both Small and Large Scale Operations

TNC, MNC Recovery and Post Thaw Viability ücritical ü Process Control

2 Introduction The SynGenX 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 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 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) F: +1 (916)

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.

3 Control Module The SynGenX 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 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. Web: sales@syngeninc.com

and close the tubing in the Disposable Cartridge, directing the red blood cells and buffy coat to their respective compartments.

4 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) F: +1 (916)

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.

5 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 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: sales@syngeninc.com

The Sterile Docking Workstation optimizes the lengths of the docked tubing.

6 P: +1 (916) F: +1 (916) Web:

7 M0002-A The SynGenX A Complete System Solution for Cord Blood Processing 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) Syngen, Inc. Web: sales@syngeninc.com P: +1 (916) F: +1 (916)

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.

14.0 Stem Cell Laboratory Services

14.0 Stem Cell Laboratory Services Laboratory Services Contact Information: To inquire about assisting with surgical harvesting of bone marrow, cellular therapy (CT) product processing, cryopreservation, storage, or any other lab services,