TriLink BioTechnologies, Part of Maravai LifeSciences, Expands its mRNA Raw Material Offering with the First GMP-grade Modified Nucleoside-Triphosphate Product
Maravai (NASDAQ: MRVI) announced the addition of GMP-grade N1-Methyl-Pseudouridine-5’-Triphosphate to its product line through its subsidiary TriLink BioTechnologies. This critical raw material enhances mRNA manufacturing, supporting researchers in accelerating drug discovery timelines while sourcing materials domestically. The demand for N1-Methyl-Pseudouridine has surged, particularly due to its role in FDA-approved mRNA vaccines. TriLink aims to strengthen its industry position by leveraging over ten years of experience in manufacturing this product.
- Introduction of GMP-grade N1-Methyl-Pseudouridine-5’-Triphosphate to support mRNA manufacturing.
- Rising demand due to COVID-19 mRNA vaccine applications.
- Over a decade of manufacturing experience positions TriLink as a leader in this space.
- Risks associated with continued demand for COVID-19 related products, which currently represent a significant portion of revenue.
- Potential competition from other nucleic acid products could impact market share.
TriLink now offers GMP-grade N1-Methyl-Pseudouridine-5’-Triphosphate, a critical raw material for mRNA manufacturing, allowing researchers to accelerate their drug discovery and development timelines and US-source their supply chain
SAN DIEGO, Sept. 13, 2022 (GLOBE NEWSWIRE) -- TriLink BioTechnologies (TriLink), a Maravai LifeSciences company (Maravai) (NASDAQ: MRVI) and global provider of life science reagents and services, has expanded its GMP-grade product offering to include N1-Methyl-Pseudouridine-5’-Triphosphate (N1meΨTP), a modified nucleoside-triphosphate (NTP) essential for mRNA manufacturing. This new product extension 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.”
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 of Manufacturing Operations, 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 catalog.” 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 synthesized capping reagents and mRNA components and see this as one of many GMP-grade reagents to come in our mRNA pipeline.”
To learn more, please visit: www.trilinkbiotech.com/modified-nucleotides.
About Maravai
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world's leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.
For more information about Maravai LifeSciences, visit www.maravai.com.
About TriLink BioTechnologies
TriLink BioTechnologies, part of Maravai LifeSciences, is a CDMO helping life science leaders and innovators overcome challenges in the synthesis and scale-up of nucleic acids, NTPs, and mRNA capping analogs with scale-up expertise and unique mRNA production capabilities, including its proprietary CleanCap® mRNA capping technology. TriLink continues to expand its cGMP and general manufacturing capacity at its new global headquarters in San Diego, California, to support mRNA, oligonucleotide & plasmid therapeutic, vaccine, and diagnostic customers.
For more information about TriLink, visit www.trilinkbiotech.com.
Forward-looking Statements
This press release may contain "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements constitute forward-looking statements, including, without limitation, statements related to the demand for GMP-grade N1-Methyl-Pseudouridine-5’-Triphosphate and other nucleic acid products, constitute forward-looking statements identified by words like “expect,” “may,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation and uncertainties related to continued validation of the safety and effectiveness of our technology, new scientific developments and competition from other products, and continued demand for our COVID-19 related products and services, which currently comprise a significant portion of our revenue. These and other risks and uncertainties are described in greater detail in the “Risk Factors” section of our most recent Annual Report on Form 10-K, as well as other reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements, and therefore you should not rely upon them. These forward-looking statements reflect our current views and we do not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.
FAQ
What is the significance of N1-Methyl-Pseudouridine-5’-Triphosphate for Maravai (MRVI)?
How does the new GMP-grade product affect Maravai's operations?
Why is there increased demand for N1-Methyl-Pseudouridine?
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