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InSphero AG

InSphero AG is a Switzerland-based preclinical service provider specializing in three-dimensional human liver model technologies. Leveraging its proprietary platforms, the company offers contract research services that accurately recapitulate pathological conditions such as drug-induced liver injury (DILI), fatty liver disease, and liver fibrosis.
In Japan, InSphero AG’s technologies and technical consultation services are supported through its distributor, Cosmo Bio.
This section provides an overview of InSphero AG’s preclinical service capabilities, representative disease models, and relevant applications.

Features of IInSphero AG’s Contract Services for Non-Clinical Studies

High-Accuracy DILI Prediction Using 3D InSight™ Technology

InSphero AG’s contract research services utilizeproprietary 3D InSight™ Liver Microtissues to assess the risk of drug-induced liver injury (DILI) in highly human-relevant, three-dimensional biomimetic liver models. Unlike conventional two-dimensional cultures, these microtissues preserve liver-specific microarchitecture and incorporate multiple human hepatic cell types in co-culture, enabling the generation of physiologically relevant toxicity data.
The platform is optimized for high-throughput screening, allowing large compound libraries to be evaluated within a short timeframe and supporting early go/no-go decision-making in drug development.
Following analysis, comprehensive study reports are provided, delivering actionable safety data directly applicable to preclinical development and clinical risk assessment.

Physiologically Relevant Liver Disease Modeling for Drug Discovery

Beyond DILI assessment,InSphero AG supports drug discovery research through advanced liver disease modeling.For chronic liver diseases such as MASLD (NAFLD) and MASH (NASH), the company offers disease-specific 3D liver microtissue models that recapitulate pathological states and enable direct comparison with healthy controls. These models allow simultaneous evaluation of efficacy and safety while providing mechanistic insights into disease biology and compound responsiveness.
Their uniform, scalable design is well suited for automated workflows, large-scale screening, and integration with advanced analytical approaches, including next-generation sequencing–based readouts.

Translational Data Generation Through Cross-Species Toxicology Assessment

InSphero AG also providestranslational toxicology studies using 3D InSight™ Liver Microtissues derived from both human and animal sources, enabling cross-species comparative assessments.This approach allows evaluation of how toxicological responses observed in preclinical animal models translate to human biology, thereby reducing uncertainty and risk during clinical transition.
Published studies have demonstrated high accuracy in detecting compounds associated with human hepatotoxicity, enabling early identification of safety liabilities that are often overlooked in conventional 2D or single-species models. Such multi-species, three-dimensional comparative modeling enhances confidence in safety assessment across the drug discovery and development pipeline.

Examples of Disease Models Available at InSphero

The 3D InSight™ Human Fatty Liver (Steatosis) Model employsthree-dimensional microtissues composed of multiple human hepatic cell types.By inducing lipid accumulation under free fatty acid and high-glucose conditions, the model reproduces key pathological features of clinically observed fatty liver disease.
Both microvesicular and macrovesicular lipid droplet formation are observed within hepatocytes, enabling in vitro assessment of metabolic dysfunction relevant to MASLD/MASH. Preservation of cell–cell interactions within the 3D architecture provides data with higher human relevance than conventional 2D culture systems, supporting efficacy testing, mechanism-of-action studies, and toxicity evaluation.

In addition, InSphero AG offersa 3D InSight™ Human Liver Fibrosis Model, which incorporates hepatic stellate cells alongside hepatocytes and other liver cell populations.Fibrosis is induced through stimuli such as TGF-β1, leading to activation of stellate cells and excessive production of extracellular matrix components, including collagen. This model closely mimics key aspects of liver fibrogenesis and is widely used as an in vitro human platform for evaluating antifibrotic drug candidates and investigating fibrosis-related mechanisms.

InSphero AG Non-Clinical Case Study

No public nonclinical case examples are currently disclosed.

InSphero AG Company Information

Address Toyo Ekimae Building, 2-2-20 Toyo, Koto-ku, Tokyo, Japan (Distributor: Cosmo Bio Co., Ltd.)
Tel +81 (3) 5632-9610
Website https://insphero.com/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Labcorp Holdings Inc.
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
  • Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

By region
list of animal models
Expertise & Track Record
3 Recommended Contract Non-Clinical Testing Services