Moderna Opens Manufacturing Site for mRNA Therapeutics

Moderna Therapeutics, a clinical-stage biotechnology company, announced the opening of its new manufacturing facility in Norwood, Massachusetts in a July 17, 2018 press release. The digitally-enabled and environmentally sustainable 200,000-ft²clinical-development manufacturing plant was built to advance Moderna’s pipeline of messenger-RNA (mRNA) therapeutics and vaccines. Designed to current good manufacturing practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase I and II clinical development programs, and to manufacture, test, and run fill/finish operations for its portfolio of mRNA development candidates.

Moderna has 21 programs in its mRNA pipeline, including potential treatments for different forms of cancer, rare diseases, infectious diseases, and heart failure. The new site also houses the company’s Personalized Cancer Vaccine (PCV) Unit for individualized supply batches of mRNA for potential personalized cancer vaccines. By making this direct investment in PCV next-generation manufacturing, the company can reduce the time it takes to manufacture a dedicated cancer vaccine for individual patients in clinical trials.

“The Norwood site is core to our long-term strategy, enabling us to leverage the potential of our mRNA platform, control our supply chain, and provide the necessary scale and flexibility to support the development of high-quality mRNA medicines for patients in the decades ahead,” said Stephane Bancel, CEO of Moderna, in the press release. “Opening this new manufacturing facility in Massachusetts was also important as it enables close collaboration with our development and research teams in Cambridge as we advance our mRNA platform and science. We are excited to continue to work with state and local partners, leverage the remarkable innovation and talent from the Massachusetts life-sciences and technology sectors, and create new biopharma manufacturing roles as we work to develop new medicines for people with serious and life-threatening diseases.”

More than 200 employees will work at the Norwood facility in a wide range of roles including production operations, manufacturing science and technology, quality control, engineering services, supply chain management, and process development. Moderna has hired more than 150 people (full time and contractors) for Norwood-based positions since the end of 2016, and the company plans to add close to 50 additional manufacturing roles in 2018.

The digitally-enabled site connects information systems, robotics, and machinery to enable the continuous exchange of data and provide information on all manufacturing activities. Using advanced algorithms and analytics, over 7000 events are monitored in real-time to help increase efficiency, ensure quality, and maintain data integrity. The site has a paperless manufacturing environment.

As part of the company’s commitment to sustainability, the manufacturing facility was designed to achieve Leadership in Energy and Environmental Design (LEED) certification. Moderna is limiting energy use with advanced energy metering, LED lighting, and systems designed to reduce water usage by up to 25%. The site will have charging stations for nearly two dozen electric vehicles, and it will deploy air quality and efficient waste-management systems. Next year, the company will also add solar panels to provide renewable energy to the building.

“Our investment in Norwood brings us even closer to the industrialization of our mRNA platform,” said Juan Andres, senior vice-president of Manufacturing for Moderna. “Norwood will allow us to own the end-to-end production of materials, run multiple programs simultaneously, and produce more than 100 cGMP batches annually in an automated and digitally-integrated environment. We believe this provides us with an important advantage as we work to develop multiple pipeline candidates for patients and to scale capacity to meet individual program demands.”

Source: Moderna