Moderna to build fully integrated GMP mRNA clinical manufacturing facility in Norwood, Mass.

Fully integrated site from raw material to API, formulation, filling and finish.

Moderna is committed to developing a broad array of medicines leveraging its leading mRNA platform, and to delivering on the promise of mRNA science for patients as quickly as possible. Moderna and its partners are simultaneously advancing mRNA drugs for many diseases toward the clinic, and the company anticipates conducting many clinical studies across its portfolio in parallel.

To support and manage this anticipated breadth of clinical studies, Moderna’s 200,000 sq ft Norwood facility will enable the manufacture, quality, control and supply of clinical grade mRNA therapies and vaccines for Good Laboratory Practices (GLP) toxicology studies as well as Phase I and Phase II clinical studies. At the site, Moderna will carry out all manufacturing activities — from raw material production to APIs, formulation, filling and finish. Moderna will begin initial build-out of the new facility in October 2016. The company plans to open the facility by early 2018.

“We are thrilled to announce the site selection for our GMP manufacturing facility, as this is a critical component of the early development engine we are building to advance many mRNA programs in parallel in human clinical studies,” said Stéphane Bancel, CEO of Moderna. “With our development pipeline expanding, we need to scale up from our current Cambridge-based GMP clinical supply manufacturing facility. Our Norwood facility will enable us to deliver our mRNA therapies and vaccines quickly, which will support rapid progression from development candidate nomination to human proof-of-concept. I’m very grateful to our team and our partners for enabling us to progress to this exciting next phase in Moderna’s history. With the addition of this new facility, we are moving a significant step closer to delivering novel mRNA medicines for patients.”

Moderna’s Norwood clinical supply facility will host GMP manufacturing and quality control; the company’s Personalized Cancer Vaccines unit; preclinical technical operations and testing; and general administrative functions to support these teams. At the facility’s opening, the annual GMP manufacturing capacity will be 40 GMP mRNA lots and is expected to scale up to over 100 GMP mRNA clinical scale lots annually in the future. Approximately 100 of Moderna’s current 460 team members will move from the company’s three existing locations in Cambridge, Mass., to the Norwood facility. In addition, Moderna plans to hire more than 100 new employees for the Norwood site.

“With the addition of this facility, we are pleased to expand our presence as a driver of innovation in Massachusetts. We appreciate the support we’ve received at both the state and local levels, and we look forward to creating new jobs and continuing to contribute to the life sciences community and the economy here in Massachusetts,” said Mr Bancel.

“This is quite an ambitious project and will result in a truly unique facility,” said Steve Harbin, Senior Vice President, Manufacturing and Operations. “We are designing the Norwood site to accommodate a broad range of GMP manufacturing needs that reflect the diversity of our pipeline — from small-scale, rapid cycle-time manufacturing of personalized cancer vaccines to larger scale Phase II clinical study supply across a number of therapeutic areas. This will be among the most integrated end-to-end process facilities I have built and seen in my 25 years working in the pharmaceutical industry.”

In addition to the Norwood facility, other key components of Moderna’s early development engine include its collaborations with leading research organizations Charles River Laboratories, to support GLP toxicology studies, and Pharmaceutical Product Development, LLC (PPD) to support Phase I and Phase II studies. The company is also building a highly automated and digital enterprise to seamlessly integrate and orchestrate cloud-based IT systems to manage and industrialize the complex planning and execution of its mRNA pipeline scale-up at every stage of development. In addition, Moderna has amassed deep institutional expertise in the US and global regulatory landscape. The ability to share and apply learnings from ongoing regulatory interactions across its ecosystem of internal therapeutically focused ventures and external partners generates a network effect that benefits Moderna and its partners, helping to advance programs through regulatory processes.