HALO®-96 PQR (Potency, Quality, Release)

 

HALO-96 PQR


HALO®-96 PQR

(Potency, Quality, Release)

 

 

HALO®-96 PQR is the only in vitro assay available that can:

1. Reliably measure and evaluate cord blood stem cell potency against a reference standard.

2. Define acceptance limits for release criteria of cord blood units for stem cell transplantation.

3. Predict potential cord blood transplantation engraftment outcome.

 

 

Information was presented at the International Society of Cellular Therapy (ISCT) Meeting in Miami, May 18-20, in the poster presentation entitled:

"A Novel Stem Cell Potency and Release Assay for Umbilical Cord Blood. Correlation of Stem Cell Proliferation with Engraftment," Abstract 168.

 

 

Updated results will be presented at ISCT, Europe to be held in Antwerp, Belgium, September 14-16, 2008

 

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You have a choice.

1. Use the HALO®-96 PQR assay kits in your own laboratory.

2. Send us your samples for testing and analysis.

HALO®-96 PQR only takes 5 days to perform. Your sample(s) will be set up on the day of arrival and a full report of results and analysis will be sent no later than 1 business day after the assay has been completed (for U.S. customers only). For more information and a quote, please call 719-264-6250 or E-mail HemoGenix® at info@hemogenix.com.

 

 

Why is Necessary to Measure Cell Potency?

  1. To ensure batch manufacturing consistency.
  2. Product stability
  3. Product bridging studies
  4. Product performance prediction / assurance
  5. Evaluate / correlate clinical dose response
  6. Avoid product failure (to engraft) or toxicity due to improper potency.

What is a Cell Potency Assay?

A cell potency assay is a measure of standardized biological activity of a sample against a reference standard. It is shown diagramatically below.

 

Cell potency

 

Compared to a reference standard, a sample can exhibit lower potency when displaced to the right of the standard or increased potency when displaced to the left of the standard. The horizontal displacement provides the measure of potency from the reference standard. Potency and a potency assay is defined in the U.S. Code of Federal Regulations (CFR).

What are the Requirements for an In Vitro Cell Potency Assay?

  1. For an assay to measure in vitro (stem) cell potency it has to exhibit certain requirements.
  2. It has to measure a specific cellular or biochemical marker.
  3. The marker has be measured using the most sensitive readout possible, otherwise parallelism of the response might not be possible.
  4. The assay has to be standardized against the same, but external cellular or biochemical marker.
  5. By standardizing the assay against an external marker, the assay can be examined as to whether it conforms to the required parameters of accuracy, sensitivity, selectivity, reliability, reproducibility and robustness, many of which are part of the validation process.
  6. A reference standard capable of exhibiting or providing the cellular or biochemical marker must be available.

HALO®-96 PQR: An In Vitro Stem Cell Potency Assay for Stem Cell Transplantation and Cord Blood Bank Processing Laboratories.

Despite the mandated use of "acceptable" and "validated" assays to detect and measure cell potency and release criteria for umbilical cord blood by Standards Organizations (FACT, JACIE, NetCord, AABB) and Regulatory Agencies (e.g. U.S. FDA), stem cell transplant centers and cord blood banks continue to use outdated, subjective, non-standardized and non-validated assays, such as the colony-forming cell (CFC) assay.The CFC assay was originally designed as a research tool and should be considered unacceptable for use in patient-related clinical applications, such as stem cell transplantation.

HALO®-96 PQR addresses all of the requirements for a stem cell potency and release assay. All of the culture and monitoring reagents are provided, included an external ATP standard with high and low controls, a frozen vial of cord blood cells as reference standard and the 96-well plates in which to perform the assay. The user must have a plate luminometer available to measure bioluminescence. Otherwise, only the target cells are required.