Moderna Therapeutics, which is pushing a pipeline of mRNA candidates into phase 2 trials, now has a manufacturing plant ready to advance its highly anticipated program.
The Cambridge, Massachusetts-based biotech opened its $110 million, 200,000-square-foot manufacturing plant today in nearby Norwood, Massachusetts. With 150 workers already on board, the company said in a release today that it will be hiring another 50 this year, which will allow it to develop materials for preclinical toxicology studies as well as phase 1 and 2 clinical development programs, and to manufacture, test and run fill-finish operations for its portfolio of mRNA development candidates.
“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.
The company is working in a new area of messenger RNA (mRNA) therapeutics and vaccines, an entirely new class of medicines that direct the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit. It is working in both cancer research and vaccines. In theory, they would enable patient cells to create the equivalent of almost any major existing biologic drug, then deliver the treatment to areas that currently cannot be reached.
The new facility will house its 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 said it can reduce the time it takes to manufacture a dedicated cancer vaccine for individual patients in clinical trials.
The company said the plant is “digitally enabled” so that information systems, robotics and machinery can continually share data and provide information on all manufacturing activities. It is monitoring more than 7,000 events in real time to improve efficiency, ensure quality and maintain data integrity, all key FDA concerns for manufacturing. Additionally, the company said the plant will have a small environmental footprint.
The privately held company recently raised $500 million in a series G round that allows it to both gather more data on its pipeline of mRNA candidates and help finance its manufacturing capabilities ahead of its long-anticipated IPO.