Our current R&D program within Immune Modulation focuses on the development of novel models within immune-oncology, immunological safety analysis and potency assays for cell therapy products.
The R&D group is located at the Bioneer headquarter facilities, where we have access to various instruments essential for the immune R&D program including a Luminex multiplexing Instrument, a FACS ARIAIII, and a MicroBeta2 reader.
Bioneer has worked with immunomodulation for more than 10 years and together with partners, we constantly develop new immune bioassays in order to investigate products’ mode-of-action and ensure quality, safety and efficacy of potential biopharmaceutical products.
Advanced predictive disease models are key for pharmacological screening and drug development. Bioneer develops platforms simulating immunosuppressive conditions as found in cancer. These models are based on interactions between tolerogenic dendritic cells (DC) and T-cells in an allogenic mixed lymphocyte reaction (MLR) assay. In addition, we focus on purification and development of different immunosuppressive immune subsets including regulatory T-cell and macrophages.
At Bioneer we know that it is essential to understand the drug safety profiles of a certain compound early in the discovery process. We investigate toxicity and safety profiling in human Peripheral blood mononuclear cells (PBMCs) and whole blood by analyzing multiplex cytokine release, which can provide a better understanding of first-in-man reactions prior to clinical trial entry.
Biological activity is extremely important for a potential drug or cellular product entering the clinic. At Bioneer we aim to develop reliable, standardized potency assays for mesenchymal stromal cell-based products using diverse cell lines in order to reflect the product’s mode of action.
Immune suppressor assays predicating suppressive capacity of different cellular subsets/products is highly relevant for development of diverse biopharmaceuticals. Such Bioassays can be used as mode of action studies for suppressive immune subsets such as: regulatory T cells, macrophages, myeloid-derived suppressor cell and mesenchymal stromal cells among others. As a second layer the suppressor assays can be used as advanced bioassays testing the immunomodulatory effect of a certain drug which e.g. aim to reverse or further stimulate the suppressive function.
At Bioneer we have Multicolor fluorescence-activated cell sorter, a FACSAria III flow cytometer from Becton Dickenson (BD) with three lasers. At Bioneer we are in a process of establishing more standardized phenotyping of clinical samples, which is essential for successful cross-study comparison of data and to minimize variability between samples measured at different time points.
> Cardiology Stem Cell Center
Bioneer is part of the Cardiology Stem Cell Center (CSCC) granted 25 MDKK by the Innovation Fund Denmark (IFD). The aim of CSCC is to solve an unmet need for novel, effective treatments of patients with ischemic heart disease and heart failure by use of adipose-derived stem cells from healthy donors. The grant from IFD is to be used to develop stem-cell treatment and to gather the documentation required by the European Medicines Agency for a new drug to be approved for general patient treatment. Read more in the press release here.
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