Current OFM developments

We are continuously improving OFM technology and extending OFM applications to new areas.

Intra-target microdosing

ITM – intra-target microdosing based on OFM technology develops an approach for the early, minimally invasive evaluation of drug candidates directly in the target tissue. Our integrated ITM system reduces development risks and enables personalized medicine based on disease- and tissue-specific biomarkers.

The development of new medicines is lengthy, costly, and associated with high failure rates. Many drug candidates fail only in late clinical stages, resulting in significant consequences for pharmaceutical companies and healthcare systems. With an innovative Phase 0 approach, we are developing an integrated Intra-Target Microdosing (ITM) system that enables the early evaluation of drug candidates directly in the target tissue — minimally invasive, safe, and clinically applicable. The system is developed within an open innovation framework together with relevant stakeholders and is validated in case studies using drug candidates from Austrian biotech companies.

Key advantages of our approach include:

Early human data on efficacy and safety
Significant reduction of development time, costs, and risks
Avoidance of late-stage, high-cost failures
Parallel testing of multiple drug candidates
Enablement of personalized therapies based on tissue- and disease-specific biomarkers

Bioavailability Prediction

Combining open flow microperfusion (OFM) technology with physiologically based pharmacokinetic (PBPK) modeling enable a better prediction of human subcutaneous bioavailability for monoclonal antibodies. This platform bridges the gap between preclinical development and human outcomes, offering a robust strategy for optimizing subcutaneous antibody formulations.

The methodology uses implanted OFM probes in a porcine model to slowly infuse monoclonal antibody (mAb) formulations into subcutaneous tissue while simultaneously sampling interstitial fluid (ISF), thereby capturing real-time antibody-tissue interactions without disturbances caused by rapid depot formation. Complementary tissue biopsies provide spatial assessments of the resultant mAb concentrations in subcutaneous adipose tissue, revealing tissue binding and retention characteristics. These data are then used to quantify critical modeling parameters including diffusion rates and non-specific tissue binding constants, while accounting for experimental nuances such as washout phases that distinguish loosely-bound from tightly-bound antibodies. These OFM-derived parameters are then integrated into human PBPK models to simulate systemic concentration-time profiles. Validation using three commercially available mAbs (alirocumab, brodalumab, secukinumab) demonstrated prediction accuracy within ±5% of their clinical bioavailability data, substantially outperforming standard modeling approaches. Notably, tissue biopsy analyses revealed an inverse relationship between local, subcutaneous mAb retention and human systemic bioavailability, providing mechanistic insights into the intrinsic uptake and distribution behaviors of these mAbs.

This integrated OFM-PBPK platform represents a significant advancement in translational pharmacology, enabling early optimization of subcutaneous mAb formulations and reducing late-stage development failures. The ability of this approach to bridge porcine preclinical data with human PKL offers pharmaceutical developers a powerful tool for rational design of antibody therapeutics.

https://www.sciencedirect.com/science/article/abs/pii/S0168365925010156