prepaCyte-CB® processing bags

Two integrally-attached processing containers attach to a third lab-provided storage container

The PrepaCyte-CB® processing system is used to isolate the greatest amount of stem cells from human umbilical cord blood. An FDA 510K approved product, PrepaCyte-CB is manufactured under FDA current Good Manufacturing Practices (cGMP). It is a completely closed, sterile system that greatly reduces the chance for contamination during processing.

PrepaCyte-CB is a two-bag device that can interconnect with any freezing and storage bag of the lab's choice (single, dual or 5-chambered). The first bag is pre-filled with the PrepaCyte-CB separation solution, and the second bag is used to separate the blood's components during processing. The system’s interconnected, closed-bag set limits cell manipulation and helps minimize environmental contamination and identification errors. PrepaCyte-CB’s bag set and separation solution are also shown to be non-toxic.

How PrepaCyte-CB Compares with Other Processing Methods

PrepaCyte-CB is the most flexible cord blood–processing method, and it offers a number of special benefits and advantages over other processing methods. The end result to the following features of PrepaCyte-CB is a reduction in the time to neutrophil engraftment:

  • PrepaCyte-CB has been shown to yield the highest number of colony-forming units (CFUs). The number of CFUs is currently the most accurate measurement to determine stem cell potency and the potential for stem cell engraftment.1,2,3
  • PrepaCyte-CB has been shown to recover the greatest percentage of CD34+ stem cells from human umbilical cord blood.
  • PrepaCyte-CB is the only processing type where TNC and CD 34+ recovery is not affected by the initial volume of the collected unit.
  • PrepaCyte-CB has also been shown to provide the greatest reduction in red blood cell (RBC) contamination compared with all other processing methods.
  • PrepaCyte-CB–processed samples have a significantly greater clonogenic potential than all current methods.

 

  PrepaCyte Hespan SEPAX
CFU Recovery % Post Thaw4 80.2 52.9 62.7
RBC Depletion %4,5,6 99 82 84.7

 

Better Treatment Outcomes

St. Louis Cord Blood Bank Study on HES and PrepaCyte Post-Transplant

(Click to view St. Louis post-transplant assessment in a new window)

The result of the differences between PrepaCyte-CB and other processing methods has been shown to lead to better treatment outcomes, with PrepaCyte-CB–processed cord blood units engrafting more quickly than any other methods. In an evaluation of the probability of and the time to patient neutrophil recovery by the St. Louis Cord Blood Bank, PrepaCyte-CB had a median time of 16 days compared with 20 days for the Hespan group.7

"After infusion of a single HES unit, 89% of patients achieved engraftment in 23 days (median 20). … After receiving a single PC (PrepaCyte-CB) unit, 91% of patients achieved engraftment in 18.6 days (median 16)."

Additionally, when the data on engraftment times from a number of public data sources were compared, PrepaCyte-CB was found to engraft more quickly than all other cord blood–processing methods.

Processing Method Days to Recovery* Public Data Source
Prepacyte-CB7 16 St. Louis Cord Blood Bank
HES7 20 St. Louis Cord Blood Bank
AutoXpress® (AXP)8 20 New York Cord Blood Center
Sepax9 21 Duke University Medical Center
HES/Sepax10 21.5 Bloodworks
HES/Sepax11 25 ClinImmune LabsA
*Recovery time is the median time to reach an absolute neutrophil count (ANC) of 500.

Benefits for the Laboratory 

PrepaCyte-CB is intuitive and easy-to-use, permitting rapid implementation within new and existing cord blood banks. PrepaCyte-CB allows batch processing and reduces "hands on" staff time. A number of cord blood banks have realized a time-savings of up to 50 minutes per cord blood unit using PrepaCyte-CB compared with the hetastarch processing method. PrepaCyte-CB also requires no costly capital equipment or maintenance fees. Only a standard laboratory centrifuge is required to concentrate desired cells after separation.

Instructions

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Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner