CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 4, 2021--
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.
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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Senior Vice President & Head of Investor Relations
Source: Moderna, Inc.