Enginzyme and AGC Develop Scalable Manufacturing Process for Critical mRNA Vaccine Component
核心洞察
Enginzyme (搜索) and AGC Inc. (搜索) have developed a scalable biomanufacturing process for N1-methylpseudouridine-5'-triphosphate (搜索) (m¹ΨTP (搜索)), a key ingredient that enhances mRNA vaccine stability and reduces immunogenicity.
The innovative process combines selective chemical methylation with multi-enzyme phosphorylation cascade, using readily available uridine as starting material while maintaining animal-free, cGMP-compliant manufacturing standards.
Initial sample material is currently available on request, with kilogram-scale commercial manufacturing planned for 2026 to meet growing demand from the expanding mRNA therapeutics market.
Enginzyme (搜索) and AGC Inc. (搜索) have unveiled a breakthrough manufacturing process for N1-methylpseudouridine-5'-triphosphate (搜索) (m¹ΨTP (搜索)), a critical modified nucleotide that enhances the stability and expression of mRNA vaccines and therapeutics while reducing immunogenicity. The companies presented their scalable biomanufacturing solution at the mRNA Health conference in Berlin, addressing the significant demand surge driven by the rapid growth of mRNA-based medical treatments.
Novel Hybrid Manufacturing Approach
The new process represents an innovative hybrid approach that combines selective chemical methylation with a multi-enzyme phosphorylation cascade. Starting with uridine, a readily available ingredient, the manufacturing process is designed to be animal-free and conform to current Good Manufacturing Practice (cGMP) standards. Production will be carried out in Europe, ensuring compliance with stringent regulatory requirements.
"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 (搜索).
The collaboration builds on enginzyme (搜索)'s proprietary pseudouridine synthesis process, leveraging the company's patented enzyme immobilization technology that enables biomanufacturing without living organisms. This approach can be deployed using the same tools and techniques used in traditional chemical manufacturing, offering lower costs and a significantly smaller environmental footprint.
Quality Assurance and Commercial Timeline
The companies have committed to comprehensive analytical characterization to ensure the m¹ΨTP (搜索) produced meets stringent commercial-quality specifications for purity, safety, and functional performance. The manufacturing process is specifically designed to minimize all critical impurities that could interfere with mRNA function, with thorough removal during purification stages.
Initial sample material is available on request for interested parties, while kilogram-scale manufacturing is planned for 2026 to meet anticipated future commercial demand. This timeline aligns with the growing need for reliable supply chains in the expanding mRNA therapeutics market.
Strategic Partnership Impact
The collaboration combines enginzyme (搜索)'s deep-tech biomanufacturing expertise with AGC Inc. (搜索)'s global manufacturing capabilities. AGC Group (搜索) operates diverse businesses spanning glass, electronics, chemicals, and life sciences, with its Life Science division providing Contract Development and Manufacturing Organization (CDMO) services across Japan, the United States, and Europe. The division covers small-molecule pharmaceuticals, agrochemicals, biopharmaceuticals, and advanced gene and cell therapies.
Enginzyme (搜索) brings specialized expertise in biocatalysis, organic chemistry, enzyme and process engineering, as well as artificial intelligence and machine learning. The company has reshaped its management team in 2025, bringing on commercially experienced leadership and launching its first turnkey biocatalyst to drive near-term commercial growth, with a focus on reaching break-even by the first half of 2027.