Maravai LifeSciences expands CleanCap mRNA capping capacity and new plasmid DNA manufacturing

Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech innovators, is expanding its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in the first quarter of 2021 and will increase TriLink’s small molecule manufacturing capacity with a focus on additional scale-up of CleanCap^®, its proprietary messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. To further address the increasing demand for mRNA development and clinical programs, the company is currently completing the construction of its plasmid DNA production facility as well.

Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity as it opened five Current Good Manufacturing Practice (cGMP) suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.

The expansion positions TriLink to meet global demand for research- and GMP-grade CleanCap^® capping reagent, nucleoside triphosphates (NTPs) and development and cGMP services for mRNA therapeutics and vaccine production. The increase in demand for these critical raw materials and active pharmaceutical ingredients (APIs) is being driven not only by COVID-19 vaccine development but also by the rapid growth in investigational mRNA therapeutics and advancements in gene editing and cell therapy such as CRISPR, base editors and CAR-T therapies.

“Biotech startups to large biopharma customers are outsourcing production to specialized CDMOs like TriLink to achieve efficiencies and ensure quality. TriLink’s second expansion provides these innovators with a single qualified and complete production partner for their nucleic acid and small molecule research and clinical programs,” said Carl Hull, CEO of Maravai LifeSciences.

“By integrating plasmid DNA production, TriLink is eliminating the risk of production slowdowns from global supply bottlenecks and streamlining the path to and through clinical trials for our customers. Other measures we’re taking include a move to a 24-hour, seven-day-a-week manufacturing schedule and regular COVID-19 testing of our workforce,” said Brian Neel, chief operating officer of TriLink BioTechnologies.

CleanCap^® is a co-transcriptional 5’ capping technology that generates a natural Cap 1 structure with higher mRNA capping efficiencies. CleanCap^® increases mRNA yields during transcription, simplifies and shortens the mRNA manufacturing process and results in higher levels of protein production. TriLink has developed a suite of CleanCap^® analogs that are tailormade for therapeutics and vaccines.

TriLink serves institutions and companies pursuing breakthroughs in vaccines, gene editing and cell therapy, next-generation sequencing, and diagnostics around the world. It recently announced a collaboration with Imperial College London (ICL) to manufacture saRNA for ICL’s promising COVID-19 vaccine project.

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