Enginzyme and AGC Collaborate on Scalable Manufacturing Process for Key mRNA Ingredient
At the mRNA Health Conference in Berlin, Enginzyme and AGC Inc. jointly presented a newly developed, scalable manufacturing process for a critical ingredient used in mRNA vaccines and therapeutics: N1-methylpseudouridine-5′-triphosphate (m¹ΨTP). The announcement highlights a significant advancement in the production of modified nucleotides that are essential to the continued growth and commercialization of mRNA-based medicines
The rapid expansion of mRNA technologies—spanning vaccines, cancer immunotherapies, rare disease treatments, and gene-editing applications—has led to unprecedented demand for high-quality modified nucleotides. Among these, m¹ΨTP plays a vital role in enhancing the performance of mRNA by improving molecular stability, increasing protein expression, and significantly reducing unwanted immune responses. As mRNA platforms move from emergency use toward long-term, large-scale therapeutic deployment, ensuring a reliable and scalable supply of such advanced raw materials has become a critical industry challenge
The collaboration between Enginzyme and AGC Inc. directly addresses this challenge by combining complementary strengths from both organizations. Enginzyme brings its proprietary cell-free enzyme engineering technology, which enables highly efficient and selective biochemical transformations without the use of living cells. AGC Inc., a global leader across multiple industrial sectors including life sciences, contributes its extensive experience in pharmaceutical manufacturing, cGMP compliance, and global-scale production infrastructure. Together, the partners aim to remove key bottlenecks in the supply chain for therapeutic-grade nucleotides and support the next wave of mRNA innovation
Central to the collaboration is an innovative hybrid production process that merges selective chemical methylation with a multi-enzyme phosphorylation cascade. The process begins with uridine, a readily available and well-characterized starting material. Through precise chemical modification and enzyme-driven phosphorylation steps, the process yields m¹ΨTP with high efficiency and reproducibility. This hybrid approach leverages the strengths of both chemical and enzymatic methodologies, enabling tight control over product quality while maintaining flexibility in scale-up
Importantly, production will take place in Europe and is designed to be animal-free and fully compliant with current Good Manufacturing Practice (cGMP) standards. This ensures suitability for use in regulated pharmaceutical applications, including clinical and commercial mRNA products. Compared with traditional chemical synthesis routes, the new process reduces overall process complexity, minimizes harsh reagents, and lowers environmental impact, aligning with growing industry expectations for more sustainable biomanufacturing solutions
“The rapid growth of mRNA therapies requires new approaches to manufacturing critical raw materials,” said Aymeric de Gantes, CEO of Enginzyme. “This elegant hybrid approach enables us to combine the high efficiency and precision of our enzyme technology with the flexibility required to achieve competitive cost targets. By integrating the strengths of both methodologies, we are able to deliver a robust and scalable solution suited for commercial mRNA applications
A key component of the collaboration is a comprehensive analytical characterization program designed to ensure that the m¹ΨTP produced through this novel process meets strict commercial-grade specifications. The partners are conducting detailed assessments of purity, safety, and functional performance, with particular focus on identifying and controlling impurities that could negatively affect mRNA stability, translation efficiency, or regulatory acceptance. Any critical impurities are minimized during synthesis and effectively removed through optimized downstream purification steps
This rigorous quality-focused approach reflects the increasing expectations of regulators and pharmaceutical developers as mRNA therapies move toward broader patient populations and long-term use. By prioritizing analytical robustness and process consistency from the outset, Enginzyme and AGC aim to provide customers with a reliable supply of m¹ΨTP that supports both clinical development and commercial manufacturing
Initial research-scale quantities of m¹ΨTP produced using the new process are currently available upon request, enabling early evaluation by mRNA developers. Looking ahead, the partners have confirmed plans to enable kilogram-scale manufacturing in 2026, positioning the collaboration to meet anticipated commercial demand and long-term supply requirements. As mRNA-based vaccines and therapeutics continue to expand across therapeutic areas, this scalable, sustainable production platform is expected to play a key role in supporting the industry’s next phase of growth
About AGC
The AGC Group is a global company with diverse business areas, including glass, electronics, chemicals, and life sciences. Its Life Science division offers CDMO services in Japan, the US, and Europe, encompassing small molecules, agrochemicals, biopharmaceuticals, and advanced gene and cell therapies.
About engenzymes
Enginzyme enables the transition to biomanufacturing by unlocking the potential of enzymes for more cost-effective and sustainable production of everyday products. The company’s patented enzyme immobilization technology allows for biomanufacturing without living organisms. It can be used with the same tools and techniques employed in traditional chemical manufacturing, but at a lower cost and with a significantly reduced environmental impact. Enginzyme boasts a multidisciplinary team of experts in biocatalysis, organic chemistry, enzyme and process engineering, as well as AI and machine learning. This elite team collaborates with global manufacturers in industries such as personal care, food, and pharmaceuticals to develop and scale complete processes, employing a high degree of automation for safe, rapid, and reliable development. With the goal of reaching profitability by the first half of 2027, the company restructured its management team in 2025, bringing on board a commercially experienced CEO and CCO. Enginzyme has also launched its first turnkey biocatalyst to boost short-term commercial growth.
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