There are some papers supporting that the in vitro study of the pharmacodynamic effect of immunosuppressive drugs (IMS) on stimulated PBMCs derived from each patient, can provide a useful way for the differentiation of patients who show clinical resistance to immunosuppressive therapies.
However, previous approaches have not evaluated all IMs within the same bioassay (experiment), and have not used easy methods for commercialization. They use 96-Well Assay Plates and progressive dilutions of IMs to test the effect over PBMCs; that, severely complicates the handling and evaluation of up to 7 IMs in terms of time and costs.
Also, results rely on the discrete number of concentration points of the same drug (predefined by the researcher) and not in a continuous concentration gradient. Therefore, it is difficult to build reliable dose/response curves. Further, this approach implies a lot of variability in the results with little precision, and it is difficult to standardize.
The value of the IMMUNOBIOGRAM® relies on the design of a bio model that:
- Simplifies considerably the IMs efficacy evaluation in terms of handling, costs and time
- Simultaneously adds precision and robustness.
- The results also consider clinical variables.
The IMMUNOBIOGRAM® is a model similar to antibiograms in the infectious disease area to guide the prescription of antibiotics.
This bio model is based on a novel design of a “channelled 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 definition of mathematical algorithms that not only evaluate dose/response curves but also is capable of clustering patients in sensitive/resistant groups combining biological results with clinical data
Altogether, the IMMUNOBIOGRAM® has become an innovative in vitro immune assay that combines a biotechnological kit and a software for data interpretation that cannot be duplicated in a normal reference lab unless having access to all the biotechnological and mathematical development reached by Biohope.