HemoGenix® Contract Services
for
In Vitro Hemotoxicity and General Toxicity Testing
and
Stem Cell Quality Control / Stem Cell Potency and Release Testing
HemoGenix® was the first company in the world to provide contract hemotoxicity testing service as its primary work. This was started when HemoGenix® came into being in June 2000. Since that time, HemoGenix® has become the leader in stem cell toxicity testing using its own proprietary in vitro, cell-based and non-invasive platforms.
Whereas others may offer subjective, non-standardized and even non-validated assays with limited population and species comparison ability and no high-throughput capability, such as the 40 year old colony-forming assay, HemoGenix® has single-handedly brought stem cell hemotoxicity and quality control/cell potency testing into the 21st century with its HALO® Platform. We have provided our contract services to small, medium and some of the largest biotechnology and pharmaceutical companies in the world. In addition, we also work with academic and clinical centers.
In Vitro Hemotoxicity and General Toxicity Testing
HALO® (Hematopoietic / Hemotoxicity Assays via Luminescence Output) is a unique assay platform that was originally developed to improve throughput of potential drug candidates and the ability to predict potential toxicity to the lympho-hematopoietic system at any stage in the drug discovery and drug development pipeline, from screening to patient monitoring during clinical trials. The HALO® Platform was designed to use primary human hematopoietic tissues (fresh bone marrow, peripheral blood and umbilical cord blood), but HemoGenix® has developed HALO® so that it can be employed for any primary animal species used in pre-clinical testing, namely non-human primate, dog, rat and mouse. The HALO® Platform offers predictive, cost-effective hemotoxicity testing which, if implemented early in drug discovery, i.e. ADME/Tox screening, can save significant time, money and animal testing dowstream and improve safety and potential risk to the patient.
The HALO® Platform has been validated against the Registry of Cytotoxicity Prediction Model and is therefore a validated cytotoxicity assay. We have developed a unique prediction paradigm that allows toxicity to the blood-forming system to be predicted on the basis of how specific cell populations respond to agents. In addition, the prediction paradigm can be used to estimate dosing for pre-clinical animal studies and even human clinical dosing.
Besides drug discovery and development applications, our platforms are also capable of testing virtually any agent using fresh primary human or animal tissue or cell lines. For this we have developed 2 other in vitro platforms, LUMENESC™ for cells of the Mesenchymal Stem Cell System and LumiSTEM™ for all other cells that exhibit proliferation characteristics. Together, the 3 Platforms, HALO®, LUMENESC™ and LumiSTEM™ constitute the HemoGenix® "In Vitro Cross-Platform Comparative Toxicity" Testing Procedure with which more than 50 cell types from 14 different cell systems can be analyzed simultaneously using a single, standardized ATP-based bioluminescence technology that allows all result to be directly compared, thereby allowing compounds and other agents to be ranked in order of toxicity and their potential organismic effects predicted.
The ATP-based bioluminescence signal detection system provides information on 4 cellular parameters simultaneously.
Because the initiation of apoptosis requires ATP, determination of the ADP:ATP ratio at the same time cytotoxicity testing is performed provides information on the mechanism of action of an agent. In addition, HemoGenix® has also developed a flow cytometric assay to detect oxidative DNA damage, the results of which can also be correlated with any of the 3 ATP-based platforms. This assay is called OxyFLOW™ and, like HALO®, LUMENESC™ and LumiSTEM™, is a fully standardized assay.
Stem Cell Quality Control / Stem Cell Potency and Release Testing
Our stem cell quality control/stem cell potency and release testing assays (HALO® SPC-QC and HALO®-96 PQR) have been specifically designed for this purpose.
Instead of using an assay (Colony-Forming Cell (CFC) Assay) that was not developed for the purpose and trying to "make" it adapt so that it could be used for clinical quality control applications, HemoGenix® has consider all of the requirements needed to develop assays that conform to Standards Organizations (FACT, JACIE, AABB) and Regulatory Agencies (FDA) for stem cell quality control and cell potency testing. These have been discussed in a White Paper.
It is the opinion of HemoGenix® that the Colony-Forming Cell (CFC) Assay does not and cannot conform to the requirements for quality control and cell potency testing. The Colony-Forming Cell (CFC) Assay is presently used as a "growth - non-growth" assay of the granulocyte-macrophage colony-forming cell (GM-CFC) population. This provides no quantitative information whatsoever.
Both HALO® SPC-QC and HALO®-96 PQR provide non-subjective, standardized (and now validated) assays that can provide stem cell transplantation and cord blood bank processing laboratories with the quantitative information they require to ascertain whether a processed sample will exhibit the proliferation response required for potential engraftment and hematopoietic reconstitution.
HALO®-96 PQR (Potency, Quality, Release) is a unique and exceptional product. It is the only assay that includes a cord blood reference standard to which the cell potency of processed cord blood samples can be compared.
HemoGenix® now offers both HALO® SPC-QC and HALO®-96 PQR Platforms not only as assay kits for stem cell processing laboratories, but also as a service to stem cell transplantation centers and cord blood banks. To see the latest peer-reviewed publication on HALO® SPC-QC click here.
For more information, please call 719-264-6150 or contact us at info@hemogenix.com.
HemoGenix® has the experience and expertise to ensure that your scientific and financial goals are met and guaranteed. We provide a fully line of service from discussing your your needs and budget (if required at your location), to implementation and future studies. We pride ourselves on repeat clients and our exceptional service which is usually more than our clients anticipated.
We look forward to working with you.