TriLink BioTechnologies, a brand of Maravai LifeSciences, has expanded its mRNA raw material offering with the first GMP-modified Nucleoside-Triphosphate (NTP) product.
The NTP leverages TriLink’s quality systems and GMP capabilities, including cleanroom manufacturing, expanded analytical testing, and process verification. The demand for N1-Methyl-pseudouridine modified mRNA has risen significantly in the past several years due to its incorporation in both FDA-approved mRNA vaccines against COVID-19.
“A key aspect of the COVID-19 mRNA vaccines is the use of a modified base, N1-methyl-pseudouridine, instead of the standard uridine base,” said Kate Broderick, Ph.D., Senior Vice President of R&D, TriLink BioTechnologies. “This modification is essential for the mRNA vaccine to work because otherwise, the delicate mRNA is quickly degraded by the immune system.”
“Our analytical capabilities for mRNA raw materials are unmatched, so it made strategic sense to apply that same level of process control to other products in our catalogue
TriLink was an early pioneer in this space as one of the first manufacturers of N1meΨTP. “Our team has been manufacturing N1-Methyl-Pseudouridine-5’-Triphosphate for over ten years now, gaining significant expertise,” said Jeremy Horton, Senior Vice President, TriLink BioTechnologies. “Our analytical capabilities for mRNA raw materials are unmatched, so it made strategic sense to apply that same level of process control to other products in our catalogue.” Together with its revolutionary CleanCap co-transcriptional mRNA capping reagent, already in billions of mRNA vaccine doses worldwide, offering GMP-grade N1-methyl-pseudouridine at GMP grade strengthens TriLink’s commitment to enabling the industry to bring breakthrough mRNA-based therapies to the clinic.
“N1-Methyl-Pseudouridine is a key raw material for the majority of mRNA therapeutics we see in development today. Our GMP-grade N1-Methyl-Pseudouridine-5’-Triphosphate allows us to address our customer’s needs to domestically source materials,” said Brian Neel, Chief Operating Officer, TriLink BioTechnologies. “We are excited to add this GMP-grade molecule to our offering of chemically synthesised capping reagents and mRNA components and see this as one of many GMP-grade reagents to come in our mRNA pipeline.”
