Safely Entering Clinical Studies: Immune Reactivity-Testing with Our Human Artificial Lymph Node Model
Your drug candidate has been successful in the pre-clinic and is ready for the next big step. Before going into costly and potentially hazardous human studies, you want to gauge its risks in an educated immune system. Our fully human 3D micro-organoid model mimics human immune response in-vitro and assesses the effects of any drug candidates - simultaneously and at the earliest point in time. We have even successfully reconstituted the TeGenero Ph I cytokine storm in-vitro, proving that our HuALN model can help avoid such serious unwanted effects. This is the closest you can get to accurately gauging your drug’s safety and success.
Our superior 3D-micro-organoid model is based on a miniaturized, perfused and aerated bioreactor for long-term cultivation of human blood-derived immune cells. When stimulated by an antigen – your drug candidate – the cells re-organize within the 3D-matrix to form immune-competent micro-organoid structures. Mode of Action and immune responses, including unwanted side-effects, can then be measured. Drug candidates can be proteins, peptides, small molecules, nucleic acids, vaccines, or cosmetics. The model simulates lymph node functionality in a long-term culture (up to 4 weeks). The constant perfusion bioreactor process enables repeated stimulations.
Our proprietary HuALN model allows the following read-outs on T-cell and B-cell levels
- Cytokine-release profiles to characterize TH1/TH2 response
- Flow cytometric characterization of cells and their surface markers
- Micro-organoid and (antigen-specific) plasma cell formation by histology / immuno-histochemical staining
- Detection of soluble IgM and IgG levels
- Analysis of antigen-specific B-cell responses - useful for the detection of Anti-Drug Antibodies (ADAs)
- Detection of antigen-specific T-cell responses (ELISPOT assay)
ProBioGen offers the HuALN technology as a service and as a license for 3rd parties, including establishment of the technology platform on site.
Advantages
- Bridging the gap between animal testing and 1st-in-man clinical trials
- Unique 3D-micro-organoid model allowing long-term culture for immunological assessment of a drug candidate
- Differentiated analytics of T-cell and B-cell responses
- Sensitive detection method for secreted antibodies such as ADAs
