Moderna Therapeutics Plans mRNA Clinical Manufacturing Facility

Moderna Therapeutics, a clinical-stage biotechnology company, has signed a long-term lease to build a GMP clinical manufacturing facility in Norwood, Massachusetts for its messenger RNA (mRNA) technology, the company announced on Sept. 21, 2016. The 200,000-ft² facility will be a fully integrated site from raw material to API, formulation, and fill/finish.

Moderna’s messenger RNA Therapeutics in vivo drug technology produces human proteins, antibodies, and novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. 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 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.

With an initial investment of $110 million, build-out of the new facility will begin in October 2016, and the company plans to open the facility by early 2018. At opening, the facility will have an annual capacity of 40 GMP clinical mRNA lots, with the ability to scale to more than 100 mRNA lots annually.

The 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. 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.

“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, in the press release. “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.”

“This is quite an ambitious project and will result in a truly unique facility,” said Steve Harbin, senior vice-president, Manufacturing and Operations, in the press release. “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.”

Source: Moderna