Moderna Announces Expansion of its Manufacturing Technology Center in Massachusetts
May 04 2021 - 08:08AM
Business Wire
Moderna, Inc. (Nasdaq: MRNA), a
biotechnology company pioneering messenger RNA (mRNA) therapeutics
and vaccines, today announced an expansion of the Moderna
Technology Center (MTC) in Norwood, MA including more than doubling
of space to transform the facility from a production and lab space
to an industrial technology center.
This expansion includes increasing the Company’s production and
lab space from approximately 300,000 square feet to approximately
650,000 square feet through renovation of existing space and
acquisition of a 240,000 square foot building located on the same
campus for expansion of its commercial and clinical activities.
“Our manufacturing facility has been core to our long-term
strategy and has enabled us to provide the scale and flexibility to
support the development of our mRNA medicines and vaccines
including our COVID-19 vaccine,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “We believe that this investment and
expansion at our technology center will allow us to continue to
optimize our mRNA products as we explore new pharmaceutical
delivery forms such as prefilled syringes and lyophilized products.
As we grow, we are committed to minimizing our environmental
footprint.”
This expansion will support a 50% increase in production of the
Moderna COVID-19 Vaccine at Moderna’s manufacturing site, which is
expected to ramp up in late 2021 and early 2022. On April 29,
Moderna announced an investment at its owned and partnered
manufacturing facilities that it expects will increase 2022 global
capacity to up to 3 billion doses of its COVID-19 vaccine,
depending upon the mix between the authorized Moderna COVID-19
Vaccine at the 100 μg dose level and potentially lower doses of the
Company’s variant booster candidates and pediatric vaccines, if
authorized. The Company also raised its 2021 manufacturing supply
forecast to between 800 million to 1 billion doses.
Additionally, this expansion includes an increase in Moderna’s
technical development capacity and preclinical production
capability with the goal of producing thousands of preclinical
samples per month for research and development. The expanded
facility will also help facilitate the Company’s increased focus
and investment in technical capabilities such as expansion of
shelf-life stability and new pharmaceutical delivery forms such as
prefilled syringes and lyophilized products.
Moderna opened its manufacturing site in July 2018. The Moderna
Technology Center manufacturing site was named the ISPE Facility of
the Future in 2019 and is among the most integrated end-to-end
process facilities in the pharmaceutical industry. Digital
technology is integrated throughout the site—the entire research,
development and production process incorporates advanced robotics,
machine learning, artificial intelligence and creative design.
Designed to Current Good Manufacturing Practices (cGMP), this
expansion gives the Company the capacity and flexibility to support
the manufacture of the Company’s commercial COVID-19 vaccine and
the other programs in Moderna’s clinical development pipeline. In
addition, the site was built with attention to environmental issues
and with LEED certification principles in mind.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. Moderna maintains alliances with
a broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
groundbreaking science and rapid scaling of manufacturing. Most
recently, Moderna’s capabilities have come together to allow the
authorized use of one of the earliest and most-effective vaccines
against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, visit www.modernatx.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including statements regarding: the Company’s
development of a vaccine (mRNA-1273) to protect against the
SARS-CoV-2 virus, which causes COVID-19; an expansion of the
Moderna Technology Center and the potential for the expansion to
facilitate advancements in new pharmaceutical delivery forms and
the roll-out of those delivery forms (including prefilled syringes
and lyophilized products); the Company’s efforts to minimize its
environmental footprint; the increase in production capacity from
the expansion of the Moderna Technology Center; the Company’s
anticipated production of doses of COVID-19 vaccine for 2021 and
2022; the scale of future production of preclinical samples for
research and development; the Company’s ability to increase
shelf-life stability for its products; and the Company’s ability to
adapt its facilities to its existing development programs. In some
cases, forward-looking statements can be identified by terminology
such as “will,” “may,” “should,” “could,” “expects,” “intends,”
“plans,” “aims,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” “continue,” or the negative of these terms
or other comparable terminology, although not all forward-looking
statements contain these words. The forward-looking statements in
this press release are neither promises nor guarantees, and you
should not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond Moderna’s control and which
could cause actual results to differ materially from those
expressed or implied by these forward-looking statements. These
risks, uncertainties, and other factors include, among others: the
fact that there has never been a commercial product utilizing mRNA
technology approved for use; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; the safety, tolerability and efficacy profile of the
Moderna COVID-19 Vaccine observed to date may change adversely in
ongoing analyses of trial data or subsequent to commercialization;
the Moderna COVID-19 Vaccine may prove less effective against
variants of the SARS-CoV-2 virus, or the Company may be
unsuccessful in developing future versions of its vaccine against
these variants; despite having ongoing interactions with the FDA or
other regulatory agencies, the FDA or such other regulatory
agencies may not agree with the Company’s regulatory approval
strategies, components of our filings, such as clinical trial
designs, conduct and methodologies, or the sufficiency of data
submitted; Moderna may encounter delays in meeting manufacturing or
supply timelines or disruptions in its distribution plans for the
Moderna COVID-19 Vaccine; whether and when any biologics license
applications and/or additional emergency use authorization
applications may be filed in various jurisdictions and ultimately
approved by regulatory authorities; potential adverse impacts due
to the global COVID-19 pandemic such as delays in regulatory
review, manufacturing and clinical trials, supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy; and those other risks and uncertainties
described under the heading “Risk Factors” in Moderna’s most recent
Annual Report on Form 10-K filed with the U.S. Securities and
Exchange Commission (SEC) and in subsequent filings made by Moderna
with the SEC, which are available on the SEC’s website at
www.sec.gov. Except as required by law, Moderna disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on Moderna’s current
expectations and speak only as of the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20210504005773/en/
Media Colleen Hussey Director, Corporate Communications
(617) 335-1374 Colleen.Hussey@modernatx.com
Investors Lavina Talukdar Senior Vice President &
Head of Investor Relations (617) 209-5834
Lavina.Talukdar@modernatx.com
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