Translational Models

Translational models for pre-clinical and clinical studies

Tissue-based tools drive drug development in both pre-clinical and clinical phases to improve the success rate of drug development. Accordingly, the FDA and EMA have expressed the view that biomarker-based drug development strategies, in combination with translational research, may offer a biology-focused approach that reduces time and cost and increases the overall likelihood of success.

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Strategic drug development in translational studies

A drug development route for success is key but often challenging and full of uncertainties. Strategies that can increase the likelihood of success are vital. The FDA and EMA recognize that biomarker-based drug development strategies, in combination with translation research, could be the solution. This approach offers a biology-focused pathway that not only reduces time and cost but also enhances the overall likelihood of success.

Nordic Bioscience combines innovative translational models with the ProteinFingerPrint Technology™ to translate findings effectively. This is facilitated by utilizing the same biomarkers across different clinical stages of development creating a link between the preclinical model and the clinic. This strategically selected development route greatly enhances the efficiency of drug development pipelines.

In essence, the integration of biomarker-based drug development strategies in translational research not only accelerates the progression of therapeutics but also increases the likelihood of success. Through advanced translational models in combination with the ProteinFingerPrint™ biomarkers, Nordic Bioscience contributes significantly to the optimization of decision-making processes in clinical development, ultimately ensuring better treatments for the patients.

We offer translational biomarker services in various indications

The translational need in extracellular matrix (ECM) biology

The need to translate results from basic to clinical research arises from the nature of initial in vitro experiments, which are simplified models of the more complex clinical setting.

For example, primary chondrocytes cultured in single-cell layers with serum have different conditions and are less clinically relevant than chondrocytes scattered in a dense ECM in the articular cartilage of a human joint.

Ex vivo cultures have slightly greater clinical relevance than in vitro experiments due to their more natural ECM environment, but are also more complex and can be more difficult to manipulate experimentally.

Nordic’s models aim to approximate the high throughput of intro studies and the superior translation of in-models by characterizing cellular function in a more transferable 3D environment.

Of course, ex vivo models are still grown under artificial conditions in the laboratory and should be supported by in vivo and clinical research.

Current models and the translational gap

A wide range of in vitro models are commonly used to test the effects of targets and the stability of profiles, and to test cellular modulation. What many of these models have in common is that they lack the necessary complexity and profiling of downstream effects on tissue, making them less suitable for translational application further down the drug development chain.

From arthritic diseases to various forms of fibrosis and cancer, the need for translational models that can accurately profile the extracellular matrix and support decision-making in clinical development is becoming increasingly important.

Nordic Bioscience’s translational models use ex vivo, fibroblast, or primary cell cultures cultured in or on appropriate matrices, allowing active profiling of tissue turnover using protein fingerprint biomarkers. For example, an in vitro model won’t provide the same depth of information as an ex vivo model would:

  • Quantitative and dynamic measurement of tissue turnover
  • In vivo replication where cells are maintained in a near-native matrix.
  • Translational from in vitro to the clinic, allowing the same biomarker to be used at different stages of development.

In vitro—Scar-in-a-Jar (SiaJ)

The prolonged Scar-in-a-Jar is a novel model that employs macro-molecular crowding to promote extracellular matrix formation, maturation, and deposition in vitro (Figure 1).

The extracellular matrix plays a crucial role in providing structural support to cells and regulating tissue repair and regeneration by acting as a reservoir for growth factors and cytokines.

Understanding the extracellular matrix dynamics is vital for developing therapeutic strategies. Using macromolecular crowding, the model becomes more 3D-like and increases complexity, making it a suitable translational model.

Afterwards, the Nordic ProteinFingerPrint™ biomarkers can be measured in the supernatants to determine efficacy, subsequently allowing for direct translation to clinical settings.

Figure 1. Extracellular matrix remodeling in-vitro Scar-in-a-Jar model

We offer translational biomarker services in various indications

Blood-based ECM biomarkers can be utilized in translational models

The 3DPROFIB model with primary fibroblasts

The SiaJ model goes 3D with the new 3DPROFIB in partnership with Ectica Technologies. This new platform offers the possibility to analyze Nordic Bioscience ECM formation biomarkers from the supernatant of fibroblasts growing in a 3D synthetic and animal-free hydrogel matrix, increasing the translational character of our model and supplementing the biomarker readout with imaging-based readouts.

This platform:

  • Studies how anti-fibrotic compounds modulate ECM production in a physiologically relevant 3D environment versus traditional 2D plastic cultures

  • Supports high-resolution phenotypic characterization via advanced imaging techniques

  • Is offered with cardiac, pulmonary, dermal fibroblasts, bone marrow mesenchymal stromal cells and hepatic stellate cells

  • Permits co-culture with inflammatory cells, endothelial cells and epithelial cells

Reach out to us about 3DPROFIB

Ectica’s proprietary 3D hydrogel fibroblast cultures

We integrate Ectica Technologies’ proprietary 3D hydrogel fibroblastic cultures into our laboratory services. By coupling this advanced matrix system with our ECM turnover biomarkers, the 3DPROFIB platform further delivers:

  • Exclusive measurement of fibroblast-derived collagen and other matrix fragments, free from background interference, for precise assessment of compound efficacy.

  • Human primary fibroblasts exhibit native morphology and behavior within the synthetic hydrogel, improving predictive value for clinical outcomes.

  • A turnkey service for anti-fibrotic drug discovery, combining high-throughput compound screening with biomarker-driven decision-making.

  • Fully human, animal-free assays that align with 3Rs principles while maintaining rigorous scientific standards.

Access to 3DPROFIB is available as part of Nordic Bioscience’s pre-clinical and translational drug discovery services. For details on implementing this ECM-driven 3D assay in your fibrosis research, get in touch with our team.

Interested in 3DPROFIB? Ectica's homepage

About Nordic Bioscience’s translational models

  • Translational models bridge the gap between basic research and clinical application by mimicking human disease processes more accurately than traditional in vitro systems. They enable early testing of drug efficacy and safety in a more biologically relevant context, improving decision-making and reducing late-stage clinical trial failures.

  • Nordic Bioscience’s models use 2D and 3D systems—like the Scar-in-a-Jar and 3DPROFIB—to simulate tissue remodeling. These models are paired with ECM biomarkers to quantify fibrogenesis and fibrolysis, enabling translational insight from pre-clinical studies to clinical trials in diseases such as liver fibrosis, pulmonary fibrosis, and cancer.

  • The SiaJ model is an in vitro system that uses macromolecular crowding to promote ECM production and maturation. It replicates fibrotic processes in a controlled environment, allowing for precise measurement of ECM turnover and drug effects using Nordic ProteinFingerPrint™ biomarkers.

  • 3DPROFIB is a next-generation translational model that uses a 3D, synthetic, animal-free hydrogel matrix to culture primary human fibroblasts. It enhances physiological relevance and allows combined biomarker and imaging-based readouts, supporting high-throughput screening and anti-fibrotic drug development.

  • Nordic Bioscience offers translational biomarker solutions across multiple indications, including inflammatory bowel disease, hepatic fibrosis, pulmonary fibrosis, rheumatology, dermatology, nephrology, and oncology—enabling more targeted, data-driven drug development.

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