Moderna lays out ambitious $110M facility for clinical supplies

Moderna lays out ambitious $110M facility for clinical supplies

Moderna Therapeutics, the much-ballyhooed Cambridge-based biotech developing a cutting-edge mRNA treatment platform, says it will build a $110 million manufacturing plant to handle the clinical trial supplies for its variety of treatment projects.

On Wednesday, Moderna announced the construction of a 200,000-square-foot facility that will handle pretty much every step of its manufacturing, from raw material and API production, to formulation and then filling and finish. It has leased land in nearby Norwood, MA, and expects to start construction next month and have the facility operating by early 2018.

The facility will be staffed with about 200 employees. That will include 100 of its 460 folks that currently work at one of the company’s three locations in Cambridge, along with another 100 new hires at the Norwood site. It will open with a capacity to produce 40 clinical mRNA lots but be able to build up to 100 lots, according to Moderna, which intends to use its mRNA platform across a number of treatments, and is also working on cancer vaccines.

“This is quite an ambitious project and will result in a truly unique facility,” Moderna Manufacturing and Operations SVP Steve Harbin said in a statement. “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.”

Moderna’s concept has attracted huge amounts of venture capital, and the company is reportedly valued at $5 billion. That concept is to create messenger RNA therapeutics to produce human proteins and antibodies and other protein constructs within a patient’s own cells. 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. Its most advanced program is in Phase II clinical trials.

Several years ago, Moderna set up a manufacturing advisory board that included Noubar Afeyan, co-founder and chairman of Moderna and himself a Ph.D. in biochemical engineering from MIT,  and 6 other noted folks, including a Nobel winner from Harvard and former executives of companies including Merck ($MRK), Genzyme, Genentech and Eli Lilly ($LLY).

by Eric Palmer | Sep 21, 2016

Source: http://www.fiercepharma.com/

September 22, 2016 / Pharma News