CAMBRIDGE, Mass. & INCHEON, South Korea – (BUSINESS WIRE) – Moderna (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing contract development fully integrated end-to-end and manufacturing service, today announced a manufacturing and supply services agreement in which Samsung Biologics will provide large-scale commercial filler manufacturing for mRNA-1273, the COVID-vaccine. 19 by Moderna.
Upon signing of the agreement, technology transfer will begin immediately at Samsung Biologics’ facilities in Incheon, South Korea, using a state-of-the-art production line equipped for aseptic filling, labeling and filling services. packaging to support production of hundreds of millions of doses of Moderna’s COVID-19 vaccine intended to supply markets outside the United States starting in the third quarter of 2021.
“This vaccine is essential for people around the world in the fight against the COVID-19 pandemic, and we really appreciate our client Moderna for having entrusted and chosen to partner with Samsung Biologics for the filling and finishing of this important vaccine, ”said John Rim, CEO of Samsung Biologics. “Due to the high degree of urgency to deliver the vaccine to the global population, we have established immediate action plans and a timeline to make mRNA-1273 available for commercial distribution early in the second half of 2021.”
“We are pleased to partner with Samsung Biologics for this fill and finish manufacturing, which will help us continue to increase our manufacturing capacity outside of the United States,” said Juan Andres, director of technical operations and Moderna quality. “We and our manufacturing partners remain committed to defeating the COVID-19 pandemic.”
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage offering programs in the field of messenger RNA (mRNA) to a company with a diverse clinical portfolio of vaccines and therapeutic products through six modalities, a large intellectual property portfolio. in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has enabled the pursuit of groundbreaking science and the rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest 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 enabled the development of therapies and vaccines for diseases infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 24 development programs are underway in these therapeutic areas, and 14 programs have entered the clinic. Moderna has been named one of Science’s Top Biopharmaceutical Employers for the past six years. To learn more, visit www.modernatx.com.
About Samsung Biologics Co., Ltd.
Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing and laboratory testing services. With proven regulatory approvals, the largest capacity and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely capable of supporting the development and manufacture of biologics every step of the way while meeting evolving needs. of biopharmacy. companies around the world. For more information visit www.samsungbiologics.com.
Moderna 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 regarding Moderna’s development of a vaccine against SARS-CoV-2 (mRNA-1273), and a Agreement under which Samsung Biologics will provide sterile filling / finishing manufacturing and packaging services for Moderna COVID-19 vaccine, as well as the timing and scale of such services. In some cases, forward-looking statements may be identified by words such as “will”, “may”, “should”, “could”, “expects”, “intends”, “intends”, “aims”, “ provides, “” Believe “,” estimate “,” predict “,” 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 contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements as 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 such forward-looking statements. These risks, uncertainties and other factors include, but are not limited to: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the manufacturing infrastructure required to make mRNA-1273 by Moderna is still under development and implementation; that the safety and efficacy of mRNA-1273 have not yet been established; the safety, tolerability and efficacy profile of Moderna COVID-19 vaccine observed to date may change unfavorably in ongoing analyzes of trial data or post-marketing; despite ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with Moderna’s regulatory approval strategies, components of our repositories, such as clinical trial designs, conduct and methodologies, or sufficiency of data submitted; Moderna may experience delays in meeting manufacturing or supply deadlines or disruptions in its distribution plans for the Moderna COVID-19 vaccine; whether and when biologic license applications and / or emergency use authorization requests can be made and ultimately approved by regulatory authorities; potential negative impacts from the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain disruptions, adverse effects on health systems and disruption the world economy; and other risks and uncertainties described under “Risk Factors” in Moderna’s latest annual report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings 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 to update or revise 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.
Samsung Biologics forward-looking statements
This press release contains certain statements that constitute forward-looking statements, including statements describing the objectives, plans or goals of Samsung Biologics. All of these forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties which could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will actually occur. Except as required by law, Samsung Biologics will not update forward-looking statements to reflect material developments that may arise after the date of this press release.