LAYER 3

Physical Systems

Microphysiological systems, organoids, and tissue chips that validate computational predictions with biological reality

Biological Platforms

Validation Systems

Organ-on-Chip

Microfluidic devices recreating organ-level physiology with flow, mechanical forces, and tissue-tissue interfaces on a microscale.

Lung-on-Chip
Liver-on-Chip
Heart-on-Chip
Kidney-on-Chip

Organoids

Self-organizing 3D tissue structures derived from stem cells that recapitulate organ architecture and cellular diversity.

Brain Organoids
Gut Organoids
Tumor Organoids
Retinal Organoids

Multi-Organ Systems

Connected chip platforms linking multiple organs to study systemic drug effects, metabolism, and organ crosstalk.

Body-on-Chip
Gut-Liver Axis
Immuno-Oncology
BBB Models

Tissue Chips

Standardized platforms supporting high-throughput screening with consistent reproducibility across experiments.

96-Well Format
384-Well Format
Custom Arrays
Automation
Measurement

Real-Time Instrumentation

Continuous Monitoring

  • Transepithelial electrical resistance (TEER)
  • Oxygen consumption rate (OCR)
  • pH and dissolved gases
  • Glucose/lactate metabolism

Imaging Modalities

  • Live-cell confocal microscopy
  • High-content phenotypic screening
  • Calcium imaging for electrophysiology
  • Label-free impedance sensing

Biochemical Assays

  • Cytokine/chemokine panels
  • Metabolite profiling
  • Secreted protein quantification
  • Drug metabolite detection
Workflow

Validation Workflow

1

Hypothesis Generation

Computational models generate predictions about drug efficacy, toxicity, or mechanism that require biological validation.

2

Experiment Design

Automated systems design optimal experiments selecting appropriate MPS platforms, cell sources, and endpoints.

3

Biological Testing

Physical systems execute experiments with continuous monitoring and data streaming to the infrastructure layer.

4

Model Refinement

Experimental results feed back to computational layer, improving model accuracy and identifying knowledge gaps.

Compliance

Regulatory Alignment

FDA MAA 3.0

Full alignment with FDA Modernization Act allowing NAMs data in regulatory submissions without requiring animal testing.

ICH S5/S7

Validated endpoints for reproductive/developmental toxicity and safety pharmacology assessments.

EMA 3Rs

Supporting European regulatory acceptance of replacement, reduction, and refinement methodologies.

OECD Guidelines

Compliance with evolving OECD test guidelines for in vitro methods and defined approaches.

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