In Vitro Modelling

Bioneer has vast experience in developing advanced in vitro models and assays which can mirror cellular or molecular aspects of diseases and in vivo conditions.

We are specialized in developing CNS models, immune models, cancer models and models within the gastro-intestinal field.

Cancer

We create cancer in vitro systems to evaluate chemotherapeutics and immuno-oncology drug candidates.
We can assist in both simple or complex studies with few or several parameters, one or more cancer drug candidates of interest, in a multicellular milieu. We can test candidates alone or in combination with relevant commercially-available reference drugs.

We have a strong expertise in immuno-oncology and can assist companies with a broad range of in vitro models and assays. These includes:

  • Immune suppressor assays including T-regs
  • Dendritic / T-cell model including immune suppressive DCs, so-called DC10s
  • Simulated tumor microenvironment by using Tumor-conditioned Media (TCM)
  • Different immortalized cancer cell models
  • Different cell co-cultures mimicking cancer micro environments
  • Detection of tumor cells in blood
  • Checkpoint inhibitor blockade
  • Reprogramming and genome editing of immune cells
  • Cytokine release assays
  • Generation of cancer-specific cell lines
  • Advanced biomarker analysis from single cells to complex tissue samples

Above is a selection of model and assays in the immuno-oncology field that we can perform. Depending on individual project and client needs, we will tailor and adapt the study set-up to fit the specific purpose.

For further information, please contact Department Head Bjørn Holst by phone or email.

We have a strong expertise in immune-oncology and can assist companies with a broad range of in vitro models and assays. These includes:

  • Immune suppressor assays including T-regs
  • Dendritic / T-cell model including immune suppressive DCs, so-called DC10s
  • Simulated tumor microenvironment by using Tumor-conditioned Media (TCM)
  • Different immortalized cancer cell models
  • Different cell co-cultures mimicking cancer micro environments
  • Detection of tumor cells in blood
  • Checkpoint inhibitor blockade
  • Reprogramming and genome editing of immune cells
  • Cytokine release assays
  • Generation of cancer-specific cell lines
  • Advanced biomarker analysis from single cells to complex tissue samples.

Above is a selection of model and assays in the immuno-oncology field that we can perform. Depending on individual project and client needs, we will tailor and adapt the study set-up to fit the specific purpose.

For further information, please contact Department Head Bjørn Holst by phone or email.

Immunology

We provide a broad range of services, support and custom-made assays within immunology, at all levels from basic research and early discovery to clinical sample evaluation. We understand the importance of ensuring quality, safety and efficacy of biopharmaceuticals in development from an immunological perspective.

Our long-standing experience in immunology has been the key driver to establish a broad range of high quality in vitro immune model assays:

  • Anti -and proinflammatory effects: We offer advanced immune disease models based on dendritic cell and T cell interactions in Mixed Lymphocyte Reaction (MLR) assays to evaluate anti -and proinflammatory effects of drug candidates. We have developed different disease-promoting cocktails to mimic different pathogenic conditions as seen in autoimmunity, allergy or cancer.

By using these models, the predictive, immune modulating in vivo effect of e.g. potential drug candidates, vaccine adjuvants or probiotics can be investigated and evaluated. The models are validated with clinically relevant compounds.

  • Immune Suppressor assays/regulatory T Cell assays: We offer Immune Suppressor Assays predicting suppressive capacities of different cellular subsets or candidate compounds, which are highly relevant for the development of a range of different biopharmaceuticals.

We also offer isolation and differentiation of different regulatory T-cell subsets.

  • Potency assays for cell products (ATMPs): To assure consistency of measures, traditional in vitro assays need translation into standard analytical methods. We offer reliable and standardized in vitro Potency Assays for analysing immune modulatory effects of cell-based products e.g. mesenchymal stromal cells and pluripotent stem cells.
  • Custom-made immune assays: We perform a diverse range of Custom-made Immune Assays and applications. We have expertise with both human, murine, rabbit and non-human primate products. We have vast experience in designing highly tailored custom immune assays with personalized parameters and endpoints.
  • We have state of the art equipment for custom made flow cytometry based phenotypic analysis (BD FACS Lyric) and for advanced sorting of immune cell subsets (BD FACSAria III platform). We do high-throughput multiplex analysis of cytokine profiles using MagPix Luminex platform.

For further information on immunology, please contact R&D manager Monika Gad by phone or email.

Our long-standing experience in immunology has been the key driver to establish a broad range of high quality in vitro immune model assays:

  • Anti -and proinflammatory effects: We offer advanced immune disease models based on dendritic cell and T cell interactions in Mixed Lymphocyte Reaction (MLR) assays to evaluate anti -and proinflammatory effects of drug candidates. We have developed different disease-promoting cocktails to mimic different pathogenic conditions as seen in autoimmunity, allergy or cancer.

By using these models, the predictive, immune modulating in vivo effect of e.g. potential drug candidates, vaccine adjuvants or probiotics can be investigated and evaluated. The models are validated with clinically relevant compounds.

  • Immune Suppressor assays/regulatory T Cell assays: We offer Immune Suppressor Assays predicting suppressive capacities of different cellular subsets or candidate compounds, which are highly relevant for the development of a range of different biopharmaceuticals.

We also offer isolation and differentiation of different regulatory T-cell subsets.

  • Potency assays for cell products (ATMPs): To assure consistency of measures, traditional in vitro assays need translation into standard analytical methods. We offer reliable and standardized in vitro Potency Assays for analysing immune modulatory effects of cell-based products e.g. mesenchymal stromal cells and pluripotent stem cells.
  • Custom-made immune assays: We perform a diverse range of Custom-made Immune Assays and applications. We have expertise with both human, murine, rabbit and non-human primate products. We have vast experience in designing highly tailored custom immune assays with personalized parameters and endpoints.
  • We have state of the art equipment for custom made flow cytometry based phenotypic analysis (BD FACS Lyric) and for advanced sorting of immune cell subsets (BD FACSAria III platform). We do high-throughput multiplex analysis of cytokine profiles using MagPix Luminex platform.

For further information on immunology, please contact R&D manager Monika Gad by phone or email.

CNS

We develop CNS models based on iPS cell lines and immortalized cell lines. Our team use gene editing, neural differentiation technologies and image based screening to develop models that mimic a specific CNS disease.
We understand the complexity of CNS in vitro modelling, and we can custom design or tailor CNS models to fit your purpose.

We develop CNS models based on iPS cell lines and immortalized cell lines. Our team use gene editing, neural differentiation technologies and image based screening to develop models that mimic a specific CNS disease.

We understand the complexity of CNS in vitro modelling, and we can custom design or tailor CNS models to fit your purpose.

Our typical work flow for developing the CNS models is:

  • Gene editing in cell line of interest to establish a disease specific lines and corresponding isogenic controls
  • Differentiation to neuronal subtypes relevant for the CNS disease of interest
  • CNS assay development
  • We have a variety of equipment to develop the best CNS assay.
  • Image based screening platform (ImageXpress Micro Confocal High-Content Imaging System Molecular Biodevices)
  • High-throughput flow cytometry analysis (BD FACS Lyric)
  • Advanced molecular analytical tools

We have established a collection of neurodegenerative disease models, such as a variety of related knock-in models with disease specific familiar and risk factor mutations (e.g. Alzheimer’s, Frontotemporal dementia) and iPSC derived blood-brain-barrier models.

We are constantly developing our CNS modelling skills and would be happy to share the latest updates.

For further information, please contact Department Head Bjørn Holst by phone or email.

We develop CNS models based on iPS cell lines and immortalized cell lines. Our team use gene editing, neural differentiation technologies and image based screening to develop models that mimic a specific CNS disease.

We understand the complexity of CNS invitro modelling, and we can custom design or tailor CNS models to fit your purpose.

Our typical work flow for developing the CNS models is:

  • Gene editing in cell line of interest to establish a disease specific lines and corresponding isogenic controls [LINK to specialized services, Gene Editing & Reprogramming]
  • Differentiation to neuronal subtypes relevant for the CNS disease of interest
  • CNS assay development
  • We have a variety of equipment to develop the best CNS assay.
  • Image based screening platform (ImageXpress Micro Confocal High-Content Imaging System Molecular Biodevices)
  • High-throughput flow cytometry analysis (BD FACS Lyric)
  • Advanced molecular analytical tools

We have established a collection of neurodegenerative disease models, such as a variety of related knock-in models with disease specific familiar and risk factor mutations (e.g. Alzheimer’s, Frontotemporal dementia) and iPSC derived blood-brain-barrier models.

We are constantly developing our CNS modelling skills and would be happy to share the latest updates.

For further information, please contact Department Head Bjørn Holst by phone or email.

Gastro-Intestinal Models

We are specialized in oral drug delivery and have developed a range of in vitro models simulating the behaviour of drugs and drug products in the gastro-intestinal tract.

We use a broad selection of cell culture models to assess drug permeability and absorption mechanism.

We have designed and implemented development strategies for oral delivery of peptides and proteins. This includes compatibility with simulated gastro-intestinal media, assessment of protease degradation, efficiency of permeation enhancers, using cell culture models, and more. We simulate the behaviour of drugs and drug products in the gastro-intestinal tract and we assess drug permeability and absorption mechanisms applying physiologically relevant media and in vitro models to simulate desired administration routes.

  • Dynamic Gastric Model (DGM) and duodenal module simulate food effect on drug products.
  • Caco-2 cell culture permeability model
  • Mucus secreting cell models

Dynamic Gastric Model

The Dynamic Gastric Model (DGM) is the only model that also simulates the different compartments of the human stomach. The DGM can digest

an entire meal, the chewed meal will be mixed with enzymes in the funnel shaped fundus/corpus compartment and the emptied to the antrum part.

In the DGM antrum the food bolus is subjected to the same forces as in vivo – and is subsequently discharged from the DGM at rates that are depending on the caloric content of the food, similar to human gastric emptying.

It is a valuable model for testing modified release systems, enteric coated formulations, gastric retention formulations, bioequivalence, food effects and alcohol induced dose dumping.

The DGM is a strong in vitro model simulating the human stomach and being able to predict the behavior of oral dosage forms.

For further information, please contact Department Head Anette Müllertz by phone or email.

We have designed and implemented development strategies for oral delivery of peptides and proteins. This includes compatibility with simulated gastro-intestinal media, assessment of protease degradation, efficiency of permeation enhancers, using cell culture models, and more. We simulate the behaviour of drugs and drug products in the gastro-intestinal tract and we assess drug permeability and absorption mechanisms applying physiologically relevant media and in vitro models to simulate desired administration routes.

  • Dynamic Gastric Model (DGM) and duodenal module simulate food effect on drug products.
  • Caco-2 cell culture permeability model
  • Mucus secreting cell models

Dynamic Gastric Model

The Dynamic Gastric Model (DGM) is the only model that also simulates the different compartments of the human stomach. The DGM can digest

an entire meal, the chewed meal will be mixed with enzymes in the funnel shaped fundus/corpus compartment and the emptied to the antrum part.

In the DGM antrum the food bolus is subjected to the same forces as in vivo – and is subsequently discharged from the DGM at rates that are depending on the caloric content of the food, similar to human gastric emptying.

It is a valuable model for testing modified release systems, enteric coated formulations, gastric retention formulations, bioequivalence, food effects and alcohol induced dose dumping.

The DGM is a strong in vitro model simulating the human stomach and being able to predict the behavior of oral dosage forms.

For further information, please contact Department Head Anette Müllertz by phone or email.

For further information
please contact:

Christian Clausen

CSO

Jette Asboe Lassen
CBO