Thursday, October 26, 2023
EnginZyme AB is a pioneering deep-tech company specializing in acellular biomanufacturing technology that harnesses the potential of enzymes to create sustainable products and processes across various industries. The company recently announced the patenting of a synthesis process for pseudouridine, an essential component of COVID-19 mRNA vaccines.
EnginZyme, in partnership with CDMO Ajinomoto Bio-Pharma Services, a company renowned for its large-scale, GMP-compliant production of small molecules and high-value chemicals, has made significant progress in providing pseudouridine at competitive prices to support the global vaccine supply chain. These companies have successfully synthesized enough pseudouridine to produce over half a billion vaccine doses in a fully GMP-compliant facility.
What distinguishes EnginZyme's enzymatic process is its eco-friendliness and efficiency, surpassing traditional chemical synthesis methods. Importantly, EnginZyme's patented enzymatic synthesis effectively eliminates a critical impurity known as alpha-pseudouridine, a byproduct associated with the chemical synthesis of beta-pseudouridine. For more detailed technical information, please visit their website.
In a significant development, the 2023 Nobel Prize in Physiology or Medicine was awarded to Katalin Karikó and Drew Weissman, who discovered more than 15 years prior to the COVID-19 pandemic that substituting pseudouridine for uridine in messenger RNA could eliminate an inflammatory side effect, thus enabling the development of mRNA-based vaccines.
During the COVID-19 crisis, the World Health Organization observed that low- and middle-income countries faced vaccine shortages due to production and supply limitations, which were exacerbated by the preferential allocation of vaccines to higher-paying governments.
EnginZyme's CEO, Karim Engelmark Cassimjee, explained, "Shortly after discovering the pseudouridine manufacturing process, we realized that we could produce a pure, cost-effective version at scale. So, we decided to leverage this discovery to enhance the resilience of the global healthcare supply chain." Mr. Cassimjee also mentioned that universities and nonprofit organizations can request free samples for research purposes.
Ajinomoto Bio-Pharma Services, emphasized the positive environmental impact of scaling a biocatalytic process and environmentally friendly preparation. He stated that this collaboration with EnginZyme aligns with their sustainability goals and has the potential to enhance the global vaccine component supply chain.
N1-methylpseudouridine-5'-triphosphate, derived from pseudouridine, plays a crucial role in stabilizing and reducing the immunogenicity of mRNA. Messenger RNA technology gained prominence with the success of COVID-19 vaccines developed by Pfizer-BioNTech and Moderna, and it continues to be adopted in a growing number of early-stage therapies and emerging vaccines.
Enzyme Development and Innovation at EnginZyme, pointed out, "The synthesis of pseudouridine using enzymes is significantly more efficient than commonly used chemical synthesis methods. This perfectly illustrates our commitment to reducing waste, energy consumption, and achieving cleaner results. Our aim is to extend this principle to the entire chemical manufacturing sector."
*GMP (Good Manufacturing Practices) regulations, enforced by the US FDA, set the standards for ensuring the appropriate design, monitoring, and control of manufacturing processes and facilities.