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Contract Services - Cell Therapy Product & Patient Sample Testing    Page   1  |  2  
 
  • Patient &
    Clinical Samples

  • Cord Blood Bankability

    mPB Collection

  • Stem Cell "Quality"

  • Stem Cell Potency

  • Engraftment &
    Reconstitution

Patient and Clinical Sample Contract Services 

 

There are several areas where HemoGenix® Contract Services can provide considerable expertise: 

  1. When umbilical cord blood units are collected, they need to be evaluated to determine if the stem cells demonstrate metabolic functionality (viability) and growth potential, prior to being transferred to permanent storage.
  2. When donors or patients are mobilized to induce an increase in peripheral blood stem cells, the collection timing is critical and may vary from patient to patient.
  3. Assessing the "quality" and potency of blood (hematopoietic) stem cell products prior to use for transplantation purposes is critical to ensure engraftment potential.
  4. Monitoring a patient after transplantation will determine time to engraftment and reconstitution ability.
  5. Monitoring a patient before, during and even after a clinical trial can predict toxicity and potential damaged to early stem and progenitor cells.

HemoGenix® has developed specific assays that allow samples to be analyzed for each of these applications events.

Please click on the page tab above to access the types of assays available. On Page 2, quality control and potency assays specific for mesenchymal stem/stromal cells (MSC) are also presented.

Please note that assays are not listed by CLIA or CAP. However, some assays are performed under GLP compliance, while others can be performed GLP or non-GLP.

 

Please contact HemoGenix® at (719) 264-6250 or email info@hemogenix.com.
We look forward to working with you. 

Umbilical Cord Blood Bankability and Optimization of Mobilized Peripheral Blood Collection

 

How HemoGenix cellular therapy assays can be integrated and help improve hematopoietic stem cell processing and testing

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How assays from HemoGenix can improve the measurement of quality and potency of cord blood

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Assessing Umbilical Cord Blood Bankability 

  • All cord blood units collected should be tested for viability and their ability to support stem cell growth prior to being permanently stored. This is in addition to all other tests that are routinely performed.
  • STEMpredict™ is a unique, 3-day in vitro assay that determines metabolic viability (cellular function) and whether the stem cells in the unit have the functional ability to proliferate.
  • STEMpredict™ is usally performed on a sample of the fresh umbilical cord blood processed to an MNC fraction. STEMpredict™ can also be used on a cryopreserved MNC cord blood sample. 
  • HemoGenix® has determined acceptance values above which stem cell growth functionality can be predicted.
  • STEMpredict™ is a high throughput assay that is capable of assessing large numbers of cord blood samples in a fast and cost-effective manner.

Assessing the Optimum Time for Mobilized Peripheral Blood Collection

  • Stem cells are mobilized in patients by consecutive administrations of granulocyte colony-stimulating factor (G-CSF). A patient may or may not "mobilize" or may "mobilize" to a lower degree than expected.
  • STEMpredict™ can help determine whether a patient has "mobilized" and the extent of the mobilization".
  • The same 3-day STEMpredict™ assay used to determine cord blood bankability can be used to rapidly determine whether stem cells have been induced as a result of G-CSF administration and whether those stem cells can be stimulated to grow.

Advantages of using STEMpredict™ Contract Services

  • Professional and confidential services assured.
  • Samples can be tested under Good Laboratory Practice (GLP) compliance.
  • All assays incorporate standards and controls and have been validated according to FDA guidelines for bioanalytical method validation.
  • Assay calibration and standardization allows results to be compared between samples over time.
  • All assays utilized ATP bioluminescence technology as a signal detection readout to provide the highest assay sensitivity available with the most reliable results.
  • All assays incorporate Suspension Expansion Culture™ (SEC™) Technology to provide the lowest variability (lowest coefficients of variation, CVs) for any assay used in hematopoietic cellular therapy.
  • After completion of the study, a results report will be sent (usually by email) within 2-3 business days.
  • STEMpredict™ is a "best practice criteria testing" platform. Click here for more information.
For more information on these contract services, please contact HemoGenix® at (719) 264-6250 or email at info@hemogenix.com. 

 

Hematopoietic Stem Cell "Quality" Contract Services

 

How HemoGenix Cell Therapy assays can be incorporated into hematopoietic stem cell processing to improve quality and potency

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How HemoGenix assay can be implemented in the cord blood pathway of quality and potency testing and patient monitoring

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For any stem cell product that requires minimal manipulation or processing, ascertaining the "quality" of the cells during the process is paramount to ensuring consistency and safety. One of the primary properties of stem cells is their ability to proliferate. 

  • Stem cell "quality" is defined as the ability of stem cells to proliferate.
  • Measuring stem cell "quality" before and after a cell processing procedure is needed to ensure manufacturing consistency and cell stability that are also necessary to produce a high potency product.
  • For hematopoietic stem cell therapeutic products, stem cell "quality" is determined using HALO®-96 SPC-QC, a patented, proprietary and validated assay that allows results to be compared to ensure stem cell "quality" remains high when being processed for patients.
  • To ascertain the "quality" of mesenchymal stem/stromal cells (MSC), MSCGlo™-96 HuQC is used.
  • To determine hematopoietic stem cell "quality", it is best to determine the proliferation ability of at least two stem cell populations; a primitive lympho-hematopoietic stem cell responsible for long-term engraftment and reconstitution and a more mature hematopoietic stem cell responsible for short-term engraftment and reconstitution.

 Applications Requiring Stem Cell "Quality" to be Assessed

There are many applications where stem cell "quality" should be determined: These include, but are not limited to:

  • Ascertaining the efficiency of new equipment and tools to fractionate and/or process cells.
  • Optimizing red blood cell reduction for umbilical cord blood to obtain a mononuclear cell fraction that has low concentrations of dead and contaminating cells that can dilute the stem cell product. 
  • Optimizing a cryopreservation procedure.
  • Assessing the "quality" of cryopreserved cells stored for long periods of time. 
  • Optimizing a thawing procedure.
  • Cell fractionation and separation procedures.

 Advantages of using HALO®-96 SPC-QC to Assess Hematopoietic Stem Cell "Quality" 
  • Professional and confidential services assured.
  • Samples can be tested under Good Laboratory Practice (GLP) compliance.
  • All assays incorporate standards and controls and have been validated according to FDA guidelines for bioanalytical method validation.
  • Assay calibration and standardization allows results to be compared between samples over time.
  • HALO®-96 SPC-QC can be used for umbilical cord blood, mobilized peripheral blood or bone marrow and purified cell populations (e.g. CD34+) from these sources.
  • All assays utilized ATP bioluminescence technology as a signal detection readout to provide the greatest assay sensitivity available with the most reliable results.
  • All assays incorporate Suspension Expansion Culture™ (SEC™) Technology to provide the lowest variability (lowest coefficients of variation, CVs) for any assay used in hematopoietic cellular therapy.
  • Studies are completed in 5 - 7 days depending on the required sensitivity.
  • HALO®-96 SPC-QC is a "best practice criteria testing" platform. For more information, please clcik here.
  • After completion of the study, a results report will be sent (usually by email) within 2-3 business days.

Please note that stem cell "quality" should not be mistaken for stem cell potency. They are two different parameters. A stem cell "quality" assay does not measure stem cell potency. However, a stem cell potency assay can measure stem cell "quality".  

 

For more information on these contract services, please contact HemoGenix® at (719) 264-6250 or email info@hemogenix.com .
We hope we can be of service to you.

Blood Stem Cell Potency Contract Services

 

How HALO-Potency can be incorporated into the process of stem cell transplantation

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How HALO-Potency can be incorporated into the process of cord blood stem cell transplantation

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    HemoGenix® is the first company to have developed and commercialize a stem cell potency assay that is validated and compliant with FDA and EMA guidelines and regulations.

    Potency assays by HemoGenix® implement "best practice criteria". For more information, please click here.

    • Potency is the engraftment potential of a stem cell therapeutic product and is one of the most important parameters to determine prior to use.
    • Potency is measured by the potency ratio of the sample to a reference standard of the same material.
    • HALO®-96 PQR is a patented, proprietary and validated assay that complies with FDA potency assay regulations.
    • HemoGenix® is the expert in stem cell potency assessment and the only company that can provide potency assessment prior to transplantation.

    Why is Measuring Stem Cell Potency so Important?

    The importance of measuring potency of a cellular therapeutic product cannot be underestimated. It is probably one of the most important parameters to measure prior to use, but also one of the most misunderstood. Potency is used to:

    • Ensure consistency during manufacture of the product.
    • Ensure stability of the product.
    • Measuring potency can avoid product failure due to incorrect potency. This is particularly the case for umbilical cord blood, which demonstrates about 20% graft failure that has been attributed to lack of or low potency.
    • Measuring potency also reduce potential toxicity.
    • A potency assay should predict whether the product can be released for use.

    All of these reasons indicate that potency is a prospective measurement, not a retrospective measurement.  

    Advantages of Using HALO®-Potency Contract Services for Hematopoietic Stem Cell Potency. 
    • Stem cell potency contract services are available for umbilical cord blood, mobilized peripheral blood, bone marrow and purified stem cells (e.g. CD34+) from these tissues.
    • Stem cell potency and quality of the tissue sample is measured using HALO®-Potency.
    • HALO®-Potency is an FDA validated assay platform that complies with FDA and EMA guidelines and regulations for potency assays.
    • Hematopoietic stem cell potency contract services are performed under GLP compliance.
    • Hematopoietic stem cell potency of the sample is measured for the lympho-hematopoietic high proliferative potential - stem and progenitor (HPP-SP) cell and the primitive hematopoietic stem cell population (CFC-GEMM) against a reference standard of the same tissue material.
    • HemoGenix® has established reference standards for umbilical cord blood, mobilized peripheral blood and bone marrow mononuclear cells that are used to determine the potency ratio of samples from the same tissues.
    • Stem cell culture is performed using Suspension Expansion Culture™ (SEC™) Technology with an ATP bioluminescence readout, the most advanced and sensitive, non-subjective signal detection system available.
    • Assay requires a minimum of only 120,000 sample cells.
    • Results available usually after 5 days of culture, but may be extended to 7 days for increased sensitivity.
    • Thanks to ATP Bioluminomics™ Technology, results from different samples can be compared over time.
    • All results are included in a Certificate of Potency Analysis (CoPA). The CoPA provides information on the stem cell potency ratio, stem cell “quality” and the release criteria. Final product release determination should be made by the Medical Director or similar authority and only after all information pertaining to the characterization of the product have been reviewed.


    Please note that when considering stem cell potency of hematopoietic cellular therapeutic products, total nucleated cell count (TNC), dye exclusion viability and detection of viable CD34+ cells reperesent "minimum testing criteria" and are not potency assays and do not comply with FDA or EMA guidelines or regulations. However, cell count and viability are necessary to use the cells to measure potency. The number of CD34+ cells also provides additional characterization information. The CFU assay is not a potency assay and is not compliant with potency assay regulations. 

    For more information on how hematopoietic stem cell potency is measure, please refer to the following article that can be downloaded: "Hematopoietic Stem Cell Potency for Cellular Therapeutic Transplantation".

     

    Please contact HemoGenix® with questions or a quote request for our hematopoietic stem cell potency service at: (719) 264-6250 or email at info@hemogenix.com.
    We look forward to working with you.

Time to Engraftment, "Global" Reconstitution and Patient Monitoring Contract Services

 

How patients can be monitored after a stem cell transplant

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How patients can be monitored after a cord blood stem cell transplant

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    Once stem cell "quality" and potency have been determined and the cells released and administered, it is then necessary to monitor the patient's response to:

    • Ascertain time to engraftment,
    • "Global" reconstitution,

    and for patients in clinical trials,

    • Monitor the patient regularly for signs of potential hemotoxicity.

    These three application are performed by HemoGenix using its HALO®-96 PMT Assay Platform.

    Time to Engraftment Contract Services

    After hematopoietic stem cell transplantation, early phase reconstitution is determined by the ability of the patient to produce red blood cells, granulocytes (neutrophils) and platelet that can be detected in the circulation. The time at which these entities are found can vary significantly, but usually occurs within 2-3 weeks after transplantation. Ahead of significant numbers of cells appearing in the circulation, primitive progenitor cells can be detected using HALO®-96 PMT to measure:

    • Erythropoietic progenitor cells (BFU-E),
    • Granulocyte-Macrophage progenitor cells (GM-CFC), and
    • Megakaryopoietic progenitor cells (Mk-CFC).

    Unlike the colony-forming unit (CFU) assay which takes between 12 - 14 days to perform, HALO®-96 PMT takes only 5 days and provides predictive information regarding the time to engraftment.

    "Global" Reconstitution Contract Services

    For remission to occur after stem cell transplantation, all cell lineages of both the hematopoietic and lymphopoietic systems must be functioning. The immune system usually reconstitutes later than hematopoiesis. However, the latter must also be shown to be tri-lineage reconstitution. To demonstrate that reconstitution is balanced, HemoGenix® provides three types of "global" reconstitution assays.

    Global" Tri-Lineage, 4-Population Hematopoietic Reconstitution

    This assay detects:

    • Primitive hematopoietic stem cell population (CFC-GEMM)
    • Erythropoietic progenitor cells (BFU-E),
    • Granulocyte-Macrophage progenitor cells (GM-CFC), and
    • Megakaryopoietic progenitor cells (Mk-CFC).

    "Global" Tri-Lineage, 5-Population Hematopoietic Reconstitution

    This assay detects:

    • Primitive lympho-hematopoietic stem cell (HPP-SP)
    • Primitive hematopoietic stem cell population (CFC-GEMM)
    • Erythropoietic progenitor cells (BFU-E)
    • Granulocyte-Macrophage progenitor cells (GM-CFC), and
    • Megakaryopoietic progenitor cells (Mk-CFC).

    "Global" 7-Population Lympho-Hematopoietic Reconstitution

    This assay detects the same 5-populations as above, but also includes the T- and B-lymphocyte lineages.

    • Primitive lympho-hematopoietic stem cell (HPP-SP)
    • Primitive hematopoietic stem cell population (CFC-GEMM)
    • Erythropoietic progenitor cells (BFU-E)
    • Granulocyte-Macrophage progenitor cells (GM-CFC)
    • Megakaryopoietic progenitor cells (Mk-CFC).
    • T-Lymphopoietic progenitor cells (T-CFC)
    • B-Lymphopoietic progenitor cells (B-CFC)

    Patient Monitoring during Clinical Trials

    To determine the response of patients to drugs and the occurnce of potential toxicity to specific stem and progenitor cell populations during clinical trials, the same "global" HALO®-96 PMT assays can be employed using a small volume of peripheral blood or bone marrow biopsy, if performed.

    Advantages of HALO®-96 PMT to Determine Time to Engraftment "Global" Reconstitution or Patient Monitoring during Clinical Trials
    • Like all other HALO® assays, HALO®-96 PMT is always calibrated and standardized prior to sample measurement. This means that the cell response can be compared directly from one sample to another over time.
    • HALO®-96 PMT measures the ability of individual cell populations to proliferate providing the most rapid and predictive information available.
    • Thanks to SEC™ and Bioluminomics™ technology, all assays provide validated, reliable and accurate results, using advanced cell culture and the most sensitive assay readout available.
    • Rapid 5 day assay turnaround time that can be extended to 7 days for increased sensitivity.
    • For patient studies and clinical trial monitoring, in particular, studies can be performed GLP or non-GLP.

    For more information on these contract services, please contact HemoGenix® at (719) 264-6250 or email info@hemogenix.com.
    We hope we can be of service to you.