EnginZyme AB, a cutting-edge technology company specializing in enzymatic biomanufacturing, has successfully patented a revolutionary process for producing pseudouridine, a critical component in mRNA-based COVID-19 vaccines.
This breakthrough not only significantly enhances the efficiency of manufacturing pseudouridine but also eliminates a troublesome impurity, alpha-pseudouridine, commonly present in chemically synthesized beta-pseudouridine. EnginZyme’s enzymatic approach has the potential to revolutionize the production of vaccine ingredients, making it cleaner, more efficient, and environmentally friendly.
EnginZyme, in partnership with CDMO (Contract Development and Manufacturing Organization) Ajinomoto Bio-Pharma Services, aims to support global efforts to strengthen the vaccine supply chain by offering pseudouridine at reduced prices to interested buyers. Notably, the companies have already produced a substantial quantity of pseudouridine, sufficient for more than 500 million vaccine doses, in a facility compliant with cGMP regulations.
The enzymatic method developed by EnginZyme represents a significant leap forward in comparison to traditional chemical synthesis techniques.
Their research, conducted over 15 years before the COVID-19 pandemic, demonstrated that substituting pseudouridine for uridine in messenger RNA could eliminate inflammatory side effects, ultimately propelling mRNA-based vaccines into the spotlight.
The COVID-19 crisis exposed a critical need for vaccine doses in low- and middle-income countries, hindered by production limitations, wealthier nations’ hoarding, and price-focused distribution. EnginZyme’s CEO, Karim Engelmark Cassimjee, noted that their cost-efficient pseudouridine production process could contribute to the resilience of the global healthcare supply chain, offering academic and nonprofit organizations the opportunity to access free samples for research purposes.
Geert Schelkens, the R&D Manager at Ajinomoto Bio-Pharma Services, emphasized the project’s sustainability aspect. The biocatalytic process brings about a notable decrease in the project’s environmental impact, aligning perfectly with their sustainability objectives. Through their collaboration with EnginZyme, Ajinomoto Bio-Pharma Services anticipates substantial enhancements in the worldwide supply chain for vaccine ingredients.
Derived from pseudouridine, N1-methylpseudouridine-5’-triphosphate plays a pivotal role in stabilizing and reducing the immunogenicity of mRNA, a technology that achieved considerable recognition through the success of COVID-19 vaccines from Pfizer-BioNTech and Moderna.
Matthew Thompson, Head of Enzyme Development and Innovation at EnginZyme, emphasized the efficiency and sustainability of enzymatic pseudouridine synthesis, which aligns with their broader vision of minimizing waste, energy consumption, and environmental impact in chemical manufacturing.
EnginZyme states that its overarching mission revolves around redefining the field of chemistry by harnessing the potential of enzymes to facilitate sustainable and cost-effective production across various industries. Their patented enzyme immobilization technology allows for biomanufacturing without the reliance on living organisms, offering a cleaner and more environmentally responsible alternative to traditional chemical processes.
