Advanced Human Primary Cell Models & Systemic Bio-Safety

CellMade bridges the gap between static chemical assays and human-relevant physiological responses by deploying low-volume, organotypic primary cell models. Designed to replace traditional animal testing with ethically aligned, human-predictive science, our advanced testing cascade evaluates intestinal barrier integrity, hepatic clearance, and systemic immune reactivity under physiological conditions. By integrating micro-transwell TEER monitoring, 3D primary hepatocyte spheroids, and multi-donor PBMC profiling into low-volume micro-workflows, we deliver the mechanistic bio-safety data required to de-risk novel formulations and satisfy rigorous EFSA safety dossiers using minimal sample mass.

• Intestinal Epithelial Barrier Models (TEER & Permeability): High-throughput Transepithelial Electrical Resistance (TEER) monitoring on micro-transwell membranes to evaluate tight-junction integrity, paracellular flux, active transport, and first-pass metabolism of novel proteins, peptides, and micro/nanoparticles.

• Primary Human Hepatocyte (PHH) Metabolic & Toxicity Models: 2D and 3D human hepatocyte spheroid models engineered for early-stage hepatotoxicity screening—measuring cytochrome P450 (CYP450) induction/inhibition, mitochondrial stress, hepatic clearance, and the biotransformation of process-related contaminants.

• Peripheral Blood Mononuclear Cell (PBMC) Immunogenicity & Systemic Safety: Primary PBMC profiling using multi-donor human pools to assess systemic inflammatory potential, innate/adaptive immune activation, and key cytokine release signatures prior to regulatory submission.