Contract Services for
Cellular Therapeutic Stem Cell "Quality" and Potency

Download the definitive article on "Hematopoietic Stem Cell Potency for Cellular Therapeutic Transplantation". 

Besides being the leader in in vitro stem cell hemotoxicity screening and testing, HemoGenix® was also the first company to provide test kits to determine hematopoietic stem cell "quality" and potency for mobilized peripheral blood, umbilical cord blood and bone marrow as well as for mesenchymal stem cells.

Unlike the tests presently used (total nucleated cell count (TNC), dye exclusion viability and detection of viable CD34+ cells), all of which provide no indication of cellular functionality, HemoGenix™ used its Suspension Expansion Culture (SEC) and bioluminomics™ technology in assays and procedures that actually measure stem cell "quality" or proliferation ability and stem cell potency or proliferation potential. In contrast to the CFU assay, which is now only required by the cord blood community, the stem cell "quality" and potency assays, HALO®-96 SPC-QC and HALO®-96 PQR, are properly standardized and can be validated. Indeed, these assays were developed so that they would comply with regulatory requirements for bioanalytical and potency assays. Those requirements require assay validation. 

Since all bioluminomics™ assays require the use of a plate luminometer, it was realized that this instrumentation may not be readily available or may involve a financial investment. Stem cell processing laboratories that desire and need quantitative, meaningful and predictive information on their manufactured stem cell products can use HemoGenix® Contract Services to measure stem cell "quality" and/or potency of their products. Our services also include determining whether processing laboratory procedures maintain stem cell "quality" and stability. Results are usually available in 5 days. For a more rapid assay, HemoGenix® can employ its STEMpredict™ assay service for results in 2-3 days.

Please contact HemoGenix® for more information and pricing.  

Contract Services for
Neurotoxicity Screening and Testing

Neurotoxicity is one of the major sources of risk for a drug. Using bioluminomics™ technology incorporated in its NeuroGlo™-Tox HT platform, HemoGenix® has partnered with ArunA Biomedical to offer neurotoxicity screening and testing. ArunA's hNP1™ target cells are used for this contract research-specific service.

hNP1™ is a human embryonic stem (ES) cell - derived neural stem/progenitor cell line. hNP1™ cells were produced from the H9 (WA09) human ES cell line, one of the ES cell lines approved by the NIH and listed in the human ES cell registry.

hNP1™ cells represent a stable, diploid, adherent and proliferating line exhibiting >90% nestin and Sox-2, both of which are proneural markers and <5% Oct-4, an ES cell marker.

The combination of bioluminomics™ and high throughput technology, using 96- or 384-well plate formats, allow these cells to be ideal targets for screening new drug candidates and other compounds.

hNP1™ cells can be differentiated into various neuronal cell types allowing additional tests to be performed on dopaminergic, glutamatergic, cholinergi, GAGA-ergic and astrocytic cell lineages.

Please contact HemoGenix® for more information on neurotoxicity testing.