Some papers support that the study in vitro of the pharmacodynamic effect of IS on stimulated PBMCs derived from each patient, can provide a useful way to differentiate patients in relation to who shows clinical resistance to immunosuppressive therapies.

Previous approaches have not evaluated all IS within the same bioassay (experiment) and do not use methods easy to commercialize. They use 96-Well Assay Plates and progressive dilutions of IS to test the effect over PBMCs. That severely complicates the handling and evaluation of up to 7 IS in terms of time and costs. Results also rely on the discrete number of concentration points of the same drug (predefined by the researcher) and not in a continuous concentration gradient, so it is complicated to build reliable dose/response curves. Further, this approach provides much variability in results with little precision, and difficult to standardize.

The value of IMBG relies on the design of a biomodel that:

  • Simplifies considerably the IS efficacy evaluation in terms of handling, costs and time.
  • Simultaneously adds precision and robustness.
  • Allows IMBG to be interpreted also considering clinical variables.

IMBG is a model similar to the antibiograms used in the infectious diseases to guide the prescription of antibiotics.

This biomodel is based on:

  •  A novel design of a “channeled well”, a 3D semisolid matrix to hold the PBMC culture, and a simple device to release the IMs into the cell culture. These are the basis for our patent, which was published by the European Patents Agency in January 2019.
  • The development of a biotech standardized method (IVD) to quantify this effect in a valid, reliable and comparable way
  • The development of mathematical algorithms that evaluate dose/response curves AND are capable of clustering patients in sensitive/resistant groups combining biological results with clinical data

Altogether, IMBG has become an innovative in vitro immune assay that combines a biotechnological kit and a software for data interpretation that currently cannot be duplicated in a normal reference lab unless having access to all the biotechnological and mathematical development proven by Biohope.