MAT Implementation
Transition your product to a GMP-compliant Monocyte Activation Test (MAT) with CellMade’s three-phased framework. We provide feasibility screening, method development, and Ph. Eur. 2.6.30/USP <1225> validation for global regulatory success.
CellMade’s structured three-phased framework ensures a seamless transition from initial risk assessment to a GMP-compliant Monocyte Activation Test (MAT). Phase I serves as a critical "Go/No-Go" gate, utilizing cytotoxicity and interference screening to identify matrix-driven suppression or enhancement of the immune response. Following established feasibility, Phase II focuses on strategic method development, where we select the optimal compendial approach (Method 1 or 2) and balance the Maximum Valid Dilution (MVD) to eliminate interference. The journey concludes with Phase III, where we perform product-specific validation across three independent batches to meet Ph. Eur. 2.6.30 standards or USP <1225> requirements for FDA market access. This rigorous process yields a comprehensive validation report, providing the "Reproducibility Premium" necessary for global batch release and scientific verification.
