Moderna says a $110 million manufacturing facility will be ready to make clinical materials for its specialized gene therapies next year, and it has snagged a former Novartis manufacturing exec to oversee its completion and scale-up.
The company said today that Juan Andres, former global head of manufacturing and supply at Novartis, has been named senior vice president of late stage technical development and manufacturing for Moderna. He spent about 20 years at Lilly before going to Novartis in 2010.
Andres will initially oversee scale-up of Moderna’s manufacturing and quality preparations for the plant it is building in Norwood, Massachusetts, which is set to come online in 2018 to make clinical supplies. He is also charged with getting the company ready for phase 3 development and commercialization, the company said.
Andres replaces Steve Harbin, who will become chief of staff and chief sustainability officer.
Manufacturing is key to Moderna’s plans to create messenger RNA (mRNA) 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. While still in development, the concept has attracted huge amounts of interest and significant venture capital.
In preparation for late-stage trials, the company started work last year on 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.
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.
While the company has held its cards close to its chest during early development, early this year it laid out some of its initial targets. It has a dozen mRNA candidates targeting a host of infectious diseases, I-O and CV diseases. Tests are now underway for five of these across the globe, including Moderna’s Zika mRNA vaccine, mRNA-1325, which started phase 1 testing late last year.