About CellMade

CellMade bridges the gap between static chemical assays and human-predictive reality, delivering an automated, microscale ecosystem for bio-functionality, safety, and regulatory compliance across the pharmaceutical and agri-food sectors. Since 2007, we have served as an independent authority on advanced alternative methods, specializing in low-volume in vitro simulations that replace resource-intensive legacy testing with high-throughput scientific precision.

Our Pyrogen Testing & Pharmaceutical Division provides the ultimate end-to-end strategy for transitioning away from animal models (RPT/LAL), guaranteeing 2026 regulatory readiness (Ph. Eur. 5.1.13 and 2.6.30). Leveraging human monocytic models, our customized validation protocols detect broad-spectrum Non-Endotoxin Pyrogens (NEPs) and resolve complex interference and Low Endotoxin Recovery (LER) phenomena. From custom assay development to full analytical procedure validation (ICH Q2) executed under a fully aligned ISO/IEC 17025 Quality Management System (QMS), we empower global manufacturers to achieve swift market authorization and absolute patient safety.

Our integrated Food Safety Division delivers an end-to-end validation suite engineered for cellular agriculture, precision fermentation, insect proteins, and advanced plant-based matrices. Operating on a high-throughput platform that requires only milligram-scale samples, we combine INFOGEST-aligned gastrointestinal modeling and human primary cell models (Caco-2 transwell models, multi-donor PBMC profiling) with ultra-sensitive molecular, compositional, and impurity profiling. From NGS genomic strain verification, HCP/residual DNA tracing, and natural anti-nutrient quantitation to bioavailability and allergenicity mapping, CellMade generates the authoritative proof of purity, safety, and substantial equivalence required to substantiate commercial claims and de-risk EFSA novel food dossiers.