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Clinical BioBanking 2017-06-13T02:44:43+00:00

Clinical BioBanking

AutoXpress(AXP®)

The AXP® is a proprietary, automated system for the isolation, collection and storage of hematopoietic stem cell concentrates from cord blood and peripheral blood.

  • Automates the volume reduction process
  • Provides consistent buffy coat concentration volumes
  • Ensures high recoveries of mononuclear cells (MNCs) in a targeted volume
  • Allows for simultaneously processing of multiple cord blood units in one centrifuge

The AXP® System includes:

  • AXP device
  • Docking station
  • Processing set
  • XpressTRAK® software
  • Accessories
  • Precise delivery of final volume target1
  • Reliable collection of all fractions: buffy coat, RBC, and plasma
  • Viable CD34+ stem cell recovery of >97% is higher than other available systems2
  • Cord blood units (CBU) processed with AXP are richer in mononuclear cells (MNC) than units conventionally processed having similar total nucleated cells (TNC)1
  • Hematocrit is consistently <30% in final storage volume.1
  • Utilizes a functionally closed processing set
  • Separate collection bags for capturing buffy coat, plasma, and RBC
  • Integrated sampling pillows for pre- and post-processing sterile sample collection
  • Transferring cord blood from collection bag can be done by:
    • sterile weld
    • spike port
  • In-line clot filter and multiple sampling ports
  • Integrated DMSO inlet filter and tubing
  • Xpress TRAK® software tracks and documents data specific to each cord blood unit processed
  • Captures sample processing data to assist with quality assurance and compliance with current good tissue practices (cGTP) and good manufacturing practices (cGMP)
  • Stores processing data in a searchable, sortable database
  • Customizable data fields and reports
  • Optional XpressLINK software allows for networking multiple computer workstations
  • Recharges the device battery
  • Provides the communication link between the AXP device and the computer workstation that has the Xpress TRAK software

BioArchive®

BioArchive® is an automated, cryogenic system used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.

  • Samples are stored at a consistent -196°C temperature
  • Constant temperature control through closed-system sample handling with robotic storage and retrieval
  • Integrated control rate freezing
  • Delivers up to 94% post-thaw cell viability2*
  • Individual storage and retrieval of cell samples results in minimal exposure to transient warming events (TWE)
  • Automated tracking of individual sample freeze curves and storage in LN2 assures maximum confidence
  • Viable CD34+ stem cell recovery is consistently > 97%, higher than other available systems1
  • Fully automated, closed system maintains cell integrity
  • Precise robotic storage and retrieval minimizes TWE
  • Over 3600 sample capacity

The BioArchive System consists of the following key components:

  • Liquid nitrogen dewar with storage rack
  • Liquid nitrogen control system for the dewar
  • Controlled rate freezer (CRF) modules
  • Sample retrieval cartridge
  • Robotic arm consisting of a barcode reader and a periscope with a canister hook necessary for storage and retrieval
  • Microprocessor control system which controls the automated functions and maintains records of the samples freeze profile and system inventory
  • Sample Management Software (SMS)
  • Computer and accessories (printer, barcode label scanner, barcode label printer, mouse, keyboard, monitor)
  • One magnetic retrieval device
  • STET controlled-rate freezing process, a sensor monitors the sample temperature
  • This individual controlled-rate freezing maintains the sample’s cell integrity during the freeze cycle
  • The CRF controls the rate of freezing based on temperature and time until the sample reaches -50°C
  • Once the sample reaches -50°C it is then moved from the CRF and is placed in an unique location for storage. It can then be independently retrieved without compromising other samples cell viability
  • Three-dimensional, 25mL, dual-compartment blow-molded freezing bag and a stainless steel canister ensures precise, uniform freezing
  • An overwrap bag adds further sample protection during storage in LN2
  • Software provides accurate, individualized, fully documented freeze and sample tracking, history, and inventory
  • Robotic arm retrieves sample via integrated bar code reader
  • Data acquisition storage information is accessed via the sample’s unique barcode
  • Software helps comply with cGMP and cGTP Requirements
  • Multiple safety controls protect cell preservation and operator
  • Magnetic stainless steel canisters firmly house overwrapped freezing bags, enabling precise robotic insertion, and retrieval from liquid nitrogen
  • Vacuum-insulated Dewar helps maintain constant temperatures and a safe environment
  • Robotic arm identifies and retrieves only the desired sample, protecting all other samples from TWE
  • Robotic functions and minimal dewar access points reduce operator exposure to liquid nitrogen
  • Insulated retrieval cartridge helps protect handler from exposure to liquid nitrogen and samples to TWE
  • Uninterrupted power supply
  • Liquid nitrogen volume control alert system
  • Series of audible alarms and screen alerts notify users of situations that need to be attended to.
REFERENCES
1. Data on file.
2. Rubenstein P. Cord blood banking for clinical transplantation. Bone Marrow Transplantation 2009; 44:635-642.
* When used in conjunction with the AutoXpress® AXP® System.