The Need for Non-Subjective and Standardized Quality Control

HALO SPC-QC CAMEO

From the outset, HemoGenix® decided that subjective and non-calibrated and non-standardized assays, such as the colony-forming cell assay, in its present form, were unsatisfactory in scientific areas where the need for efficient, instrument-based assays was a prerequisite. Subjectivity may be acceptable in some research areas, but it is not acceptable where patients lives are at stake.

The colony-forming cell assay, in the form that has been used for over 40 years, does not measure up to the technical standards required for stem cell potency assays and stem cell toxicity detection. The need to remove subjectivity and guesswork is implicit in these technical requirements. This acceptance, recognition and development of advanced assay systems has been the mission of HemoGenix®.

Without a non-subjective and fully standardized assay to determine the proliferative / growth potential of processed stem cells, laboratories cannot

  • compare results,
  • compare the utility of different procedures, and
  • cannot perform proficiency testing to ensure that their procedures are actually working correctly under standard operating conditions.

HemoGenix® has therefore specifically designed and developed 3 stem and progenitor cell potency assay platforms:

  • HALO®-96 MeC (Methylcellulose) Stem and Progenitor Cell - Quality Control (SPC-QC) Potency Platform
  • HALO®-96 SEC (Suspension Expansion Culture) Stem and Progenitor Cell - Quality Control (SPC-QC) Potency Platform
  • CAMEO™-96 STD, the only bi-functional, colony-forming differentiation potency cell assay that is standardized against an instrument-based ATP bioluminescence proliferation readout.