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Contract Services

 

HemoGenix® Contract Services - Overview

 

21st Century In Vitro Contract Services 

With the help of SBIR grants from the National Cancer Institute, HemoGenix developed HALO®-Tox HT, the most advanced, high-throughput hemotoxicity testing platform available. Validated against the Registry of Cytotoxicty Prediction Model and according to FDA Bioanalytical Method Validation Guidelines, the HALO® Platform provided the basis for several other high-throughput cell testing platforms (ImmunoGlo™, MSCGlo™ and STEMGlo™), which can be multiplexed with numerous other assay readouts. 

 

Working with academic and governmental institutions, small, medium and half of the top 50 biopharmaceutical companies in the world, HemoGenix® has become the Leader in Hemotoxicity Testing and promotes the practice of the 3Rs (Reduce, Refine and Replace) to help reduce the need for animal testing, by providing an high degree of in vitro to in vivo concordance for its testing platforms.

 

HemoGenix® also works with many large CROs to help accumulate data from pre-clinical animal models using in vitro-based assay systems. In this way, information on toxicity, efficacy and risk assessment can be obtained using methodologies that would otherwise be impossible using traditional protocols.

Many of our testing capabilities are also applicable to the field of regenerative medicine. This encompasses many aspects of cell-based therapies, gene therapy, biologics, small molecule and drug testing as well as the effects of different materials, including nanoparticles, on different cell types. 

 

The list below shows our capabilities, which are addressed in more detail in the pages that follow.

Thank you for considering HemoGenix your contract service outsourcing provider.

 

Contract In Vitro Service Capabilities 

 

Contract Services Workflow

All of our contract services are customized to suit our client's goals and budget.

  • The CSO of HemoGenix® will consult with our clients and advise them regarding the best procedure and assays to perform to achieve the goal(s) of the study.
  • A nondisclosure/confidentiality agreement (NDA/CDA) will be signed.
  • A quote will be prepared and revised to suit the client's budget.
  • All studies are QA audited throughout the workflow regardless of whether thay are GLP or non-GLP compliant.
  • Prior to the start of any study, a detailed Study Plan will be prepared by the Study Director for the Study Monitor's / Sponsor's approval.
  • Sponsor ships test articles for study.
  • The target cells/tissues for the study will be procured.
  • The study will be initiated upon arrival of the target cells or tissues.
  • Most in vitro studies are completed within 7-14 days.
  • Phase I Report is usually provided within 4 - 7 business days after study completion.
  • Phase II Final Report is generated after all comments and corrections have been made and the final QA audit performed.
  • Once the Phase II Report has been delivered, the study will be terminated.
  • Three copies of the complete study will be held in the HemoGenix® archives.
Parameters Used to Define a Study
  • Number of compounds or test articles.
  • Dose range and number of doses (usually 6-12) to be tested (if applicable).
  • Number and type of reference, positive and/or negative controls.
  • Primary assay(s) to be used and add-on assays (if required) to be performed.
  • Type and number of cell populations to be tested.
  • Type and number of species to be tested. 
  • Type of test compound addition (if applicable):
    • Timed pre-culture addition.
    • Direct addition for culture duration.
    • Timed post-culture addition.
  • Special culture conditions, if required.
  • Sample analysis / curve-fit analysis, type and number of EC/IC values (if relevant) and statistics (if applicable).
  • GLP / non-GLP/QA audit.

NOTE: Unless otherwise required by the Study Monitor/Sponsor, HemoGenix® will perform all compound studies blind. 

Deliverables

Regardless of the type of study, the following deliverables are provided.

  • Study plan prior to initiating the study. The study plan must be accepted by the Study Monitor/Sponsor prior to starting the study.
  • Continuous up dates regarding the study.
  • QA auditing.
  • Phase I Draft Report providing the text version of the study and results, including:
    • Protocol,
    • IC/EC values,
    • Ranking with respect to compound IC/EC value(s), species, cell types (where applicable),
    • Estimation of in vitro to in vivo starting doses (where appropriate).
    • Results in graphical form.
  • Phase II Final Report and Study Termination including:
    • All corrections and comments provided by the Study Monitor.
    • All aspects in Phase I Draft Report.
    • QA manager audit certification.
    • All raw data provided as hard- and electronic copy. 
Consultation and Presentations

It is part of the HemoGenix® Contract Services Workflow to provide its clients with the best possible advice and consultation in order to achieve the goals of the study. This includes either face-to-face discussions or voice and/or video teleconferences to ensure that our clients understand the background of what we do and how we do it.

 

For those who are interested in stem cell biology and toxicology, how cells should be assessed in cellular therapeutic and regenerative medicine applications and other topics, HemoGenix® can provide speakers for schools, training and conferences.

Training

For those who prefer to perform HemoGenix® assay in-house using assay kits, HemoGenix® provides 2-4 day training sessions. These training sessions include the background biology used to interpret the results as well as hands-on practical work that will allow the immediate use of HemoGenix® products. Training can be performed either at the HemoGenix® facility in Colorado Springs, Colorado or at the user’s facility. Please contact HemoGenix® for more information.