At the mRNA Health conference in Berlin, enginzyme and AGC Inc. presented a scalable process to produce a key mRNA vaccine and therapy ingredient, N1-methylpseudouridine-5'-triphosphate (m¹ΨTP).

The rapid growth of mRNA-based vaccines and therapeutics has driven significant demand for modified nucleotides like m¹ΨTP, which enhances mRNA stability and expression, while reducing immunogenicity.

Enginzyme is a deep-tech company delivering optimized biomanufacturing solutions through cell-free enzyme engineering technology. AGC Inc. is a leading global player in fields spanning from architectural glass to chemicals and life science. AGC Inc. provides services in a wide range of life science fields, from synthetic pharmaceuticals and agrochemicals, to biopharmaceuticals and leading-edge cell and gene therapies, as well as messenger RNAs. The presentation in November detailed the latest collaboration between the companies, with a focus on the biomanufacturing of nucleotides for mRNA therapy, building on enginzyme's proprietary pseudouridine synthesis process.

The new process is innovative, combining selective chemical methylation with a multi-enzyme phosphorylation cascade. Uridine, a readily available ingredient, is the starting material. Manufacturing, which will be carried out in Europe, is designed to be animal-free and conform to 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 at enginzyme.

The companies plan a comprehensive analytical characterization to confirm that the m¹ΨTP produced by this new process meets stringent commercial-quality specifications for purity, safety, and functional performance. All critical impurities that could interfere with mRNA function are minimized during synthesis and thoroughly removed during purification.

Initial sample material is available on request; kilogram-scale manufacturing is planned for 2026 to meet future commercial demand.