cGMP Facility Streamlines Clinical &
Commercial mRNA Drug Substance Development; Built by mRNA &
Industry Experts to Meet Demand for mRNA-based Medicine
TriLink BioTechnologies (TriLink®), a Maravai
LifeSciences company (NASDAQ: MRVI) and global provider of life
science reagents and services, has announced the grand opening of
its new cGMP mRNA manufacturing facility. The 32,000-square-foot
facility was specifically designed for mRNA manufacturing to
support late-phase drug developers from Phase 2 to
commercialization via TriLink’s robust mRNA manufacturing
capabilities. The milestone opening is expected to help advance the
field of mRNA-based medicine as developers flock to leverage the
promising modality for a growing list of indications.
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the full release here:
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TriLink BioTechnologies® Cuts Ribbon on
New San Diego Facility for Late Phase mRNA Drug Substance
Production (Photo: TriLink BioTechnologies®)
Located in the Sorrento Valley area of San Diego, the facility
features individual Grade C cleanroom suites for mRNA
manufacturing, increased mRNA capacity (1g to >100g per batch),
comprehensive in-house analytical services, and laboratory space
for on-site quality control testing. The manufacturing suites are
outfitted with state-of-the-art equipment and ready to onboard
clients with late-phase manufacturing needs.
“This facility is expected to help move the needle for
life-saving breakthroughs in mRNA-therapeutics,” explained Kevin
Lynch, Vice President & General Manager of TriLink’s GMP
Operations. “The high-quality manufacture of mRNA drug substances
is critical to ensuring the safety and efficacy of this new class
of medicines for patients.”
Company and site leadership and industry guests gathered on
April 17 to celebrate the facility’s grand opening with a ribbon
cutting, expert-led panel discussion, and site tours – all centered
around a core theme: Building the Future of mRNA. The
thought-provoking panel included insights on the mRNA regulatory
landscape, manufacturing evolution, and next-generation tools.
TriLink has reliably delivered GMP services to drug developers
since the debut of its first cGMP facility in 2015. Since then, the
company’s dedicated team of scientists has provided over 1,000
clients with custom mRNA synthesis, supported 350+ programs in
biopharma development pipelines, and delivered over 100 GMP mRNA
manufacturing batches.
“TriLink’s depth of industry experience – which spans over 25
years – coupled with its capabilities makes for an unmatched
partner,” shared Drew Burch, President of Nucleic Acid Production.
“This new facility codifies our commitment to advancing the field
by playing a key role in the development of mRNA-based in vivo gene
editing, gene-edited cell therapies, protein replacement therapies,
cancer vaccines, and infectious disease vaccines.”
In addition to CDMO services and unique mRNA, oligonucleotide,
NTP, and plasmid production capabilities, TriLink has developed the
award-winning CleanCap® mRNA capping technology used in the
majority of approved COVID-19 mRNA and saRNA vaccines, adding
momentum to the rapidly growing field.
To learn more about TriLink’s products and services, visit
trilinkbiotech.com.
About TriLink BioTechnologies
TriLink BioTechnologies, a Maravai LifeSciences company, is a
global leader in nucleic acid and mRNA solutions. TriLink delivers
unrivaled chemical and biological experience, CDMO services, and
high-quality readymade and custom materials, including its patented
CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech
disruptors, and world governments depend on TriLink to meet their
greatest challenges, from delivering the COVID-19 vaccine at warp
speed, to empowering innovative treatments in oncology, infectious
diseases, cardiology, and neurological disorders, to enabling
future pandemic response plans.
For more information, visit trilinkbiotech.com.
About Maravai LifeSciences
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.
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 expectation that the facility will help advance the field of
mRNA-based medicine and will help move the needle for life-saving
breakthroughs, constitute forward-looking statements identified by
words like “expect,” “estimate,” “may,” “soon,” “nears,” “slated,”
“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, operational
risks and competition. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240418722567/en/
Investor Contact: Deb Hart Maravai LifeSciences + 1 858-988-5917
ir@maravai.com
Media Contact: Liz Robinson of CG Life TriLink BioTechnologies
+1 312-997-2436 lrobinson@cglife.com
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