At the mRNA Health Conference in Berlin, Enginzyme and AGC revealed a breakthrough scalable process to produce N1-methylpseudouridine-5'-triphosphate (m¹ΨTP), a critical component in mRNA vaccines and therapies.
The move comes amid a surge in mRNA-based therapeutics, where demand for modified nucleotides like m¹ΨTP is skyrocketing. The compound boosts mRNA stability and expression while reducing immunogenicity, making it indispensable for next-generation medicines.
Enginzyme, a deep-tech company specializing in cell-free enzyme engineering, and AGC Inc., a global life sciences and chemical leader, outlined a collaboration aimed at optimizing nucleotide biomanufacturing. Their joint effort builds on Enginzyme’s proprietary pseudouridine synthesis process and pushes toward commercial-scale production.
The newly unveiled method combines selective chemical methylation with a multi-enzyme phosphorylation cascade, using uridine—a widely available ingredient—as its starting point. Production, set for Europe, will be animal-free and fully compliant with cGMP standards.
“This elegant, hybrid approach allows us to leverage the efficiency and precision of our enzymes while remaining flexible and within cost targets,” said Aymeric de Gantes, CEO of Enginzyme.
The partners will conduct thorough analytical characterization to ensure the m¹ΨTP meets strict commercial-quality standards for purity, safety, and functional performance. Critical impurities that could interfere with mRNA function are minimized during synthesis and meticulously removed in purification.
Initial sample material is already available on request, with kilogram-scale manufacturing slated for 2026 to meet anticipated commercial demand.
