Advancements Expected to Accelerate Development of mRNA Therapeutics
SAN DIEGO – TriLink BioTechnologies, a Maravai LifeSciences company and a leader in the production of nucleic acids such as DNA and RNA, announced today that the United States Patent and Trademark Office has issued two new patents to the company. Both patents cover advancements in TriLink’s CleanCap® technology for the co-transcriptional capping of messenger RNAs (mRNAs). Capping is an important step in the production of synthetic mRNA, which is used to develop nucleic acid therapeutics that deliver instructions to cells to produce proteins that may prevent or correct disease.
U.S. Patent 10,519,189 is directed to capped trinucleotide primers and U.S. Patent 10,494,399 is directed to capped tetranucleotide primers. The technology encompassed by these two patents is not limited to any particular sequences and facilitates the production of mRNAs containing the major natural cap structures found in humans, a significant improvement over legacy co-transcriptional capping methods. As a result, CleanCap maximizes mRNA expression in vivo and helps avoid innate immune responses.
“Capping is a critical process in creating viable mRNA constructs that remain biologically active without eliciting immune responses,” explains Anton McCaffrey, Ph.D., Senior Director of Emerging Science and Innovation for TriLink BioTechnologies. “By changing the capping approach and streamlining the manufacturing workflow, we can deliver a novel solution, whether customers purchase CleanCap in bulk for their own mRNA development programs or utilize mRNA synthesized by TriLink BioTechnologies that already incorporates this new capping technology.”
CleanCap overcomes many drawbacks of existing approaches, enabling the reproducible, high-efficiency production of capped mRNA. CleanCap technology allows capping to occur in a single reaction, streamlining the manufacturing of mRNA at large scales. Reduced manufacturing time is critical for a number of emerging applications, such as the development of personalized cancer therapeutics and during rapid vaccine responses to pandemics. CleanCap also reduces the cost of mRNA manufacturing, accelerating the introduction of new mRNA therapeutics.
Founded in 1996, TriLink BioTechnologies is a global leader in the synthesis of custom RNA, DNA and oligonucleotides used throughout the genomics industry. TriLink’s highly modified nucleic acid products are instrumental in the fields of gene and oligonucleotide therapy, gene editing and molecular diagnostics. The company is ISO 9001:2015 certified and operates multiple cGMP suites for manufacturing high-quality nucleic acids in San Diego. TriLink has just built and occupied a 100,000 square foot facility that will also allow the manufacture of CleanCap in large scales under increasingly stringent quality standards, including cGMP conditions.
Maravai LifeSciences provides reagents and services to life science researchers and biotech partners that enable breakthrough discoveries and improvements in human health. Maravai’s businesses focus on DNA and RNA synthesis, bioprocess impurity testing and research immunohistochemistry and immunofluorescence. Maravai is a portfolio company of GTCR, a leading private equity firm focused on investing in growth companies in healthcare, technology and information services and financial services.
David Weber, Chief Commercial Officer