CAMBRIDGE, Mass. & FARGO, N.D.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Aldevron, LLC, the leading provider of high-quality plasmid DNA, mRNA and recombinant proteins necessary for vaccines, gene and cell therapy, gene editing and diagnostic applications, have announced their expanded collaboration in support of the Moderna COVID-19 Vaccine and additional programs in Moderna’s clinical development pipeline.
Specifically, Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.
“Aldevron has been a long-standing partner of Moderna. We appreciate their collaboration and their expertise in the biologics space,” said Juan Andres, Chief Technical Operations and Quality Officer of Moderna. “We look forward to our ongoing work with this expanded partnership.”
“Aldevron’s support of the Moderna pipeline spans nearly a decade, and we’re incredibly proud of the trust they’ve placed in us” commented Kevin Ballinger, Chief Executive Officer of Aldevron. “Our deep experience, coupled with enhanced operational efficiencies and recent capacity expansion place us in an excellent position to support Moderna’s efforts – especially during this critical time. We look forward to expanding our strategic partnership to serve a pipeline of important new programs in the future.”
Aldevron’s production of DNA continues to take place in its 70,000 sq ft GMP facility located in Fargo, North Dakota. Buildout and validation of an additional 189,000 sq ft expansion to the GMP facility on Aldevron’s 14-acre Breakthrough Campus has been completed, enabling additional manufacturing capacity.
Aldevron is a premier manufacturing partner in the global genetic medicine field. Founded in 1998 by Michael Chambers and John Ballantyne, the company provides critical nucleic acids and proteins used to make gene and cell therapies, DNA and RNA vaccines, and gene editing technologies. Aldevron’s 600 employees support thousands of scientists who are developing revolutionary treatments for millions of people.
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 14 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.
Moderna’s 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: the supply by Aldevron of plasmid DNA for Moderna products, including the Company’s COVID-19 vaccine. 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; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna’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 emergency use authorization applications may be filed 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.