Starting in a few weeks, Moderna will begin work on the biggest biotech manufacturing facility in the world dedicated to early stage R&D, producing its messenger RNA drugs for everything from tox work through Phase II studies. And with the first critical round of clinical data due to arrive in H1 2017, Moderna CEO Stephane Bancel says the biotech is already blueprinting another facility that may well dwarf the first $110 million manufacturing project.
Bancel and his executive crew have landed a site for their first 200,000-square-foot facility in Norwood, MA, not far from the biotech’s headquarters in Cambridge. And characteristically, they’re moving as fast as they can to get the dirt flying.
Moderna is thinking big about every aspect of drug development. That starts with raising cash: Now close to $2 billion. Staff: 460 and growing fast. And pipeline projects: 11. There are also four spinout ventures working on personalized cancer vaccines and oncology, infectious diseases and rare ailments.
The score on human trial outcomes? Zero so far, but that will soon change.
This new facility will eventually be able to make up to 100 mRNA lots annually, a number that won’t mean much to anyone not schooled in biotech manufacturing. But the explanation provides some insights into what Moderna has set out to achieve.
In the first dozen programs to make it to the clinic, explains Bancel, investigators can mix mRNA in a single vial, or lot. But in the very near future, they’ll need several different antigens in the same vial, or several lots. For one upcoming vaccine study for a particularly tough virus that Moderna plans to tackle, it will take seven.
And after Phase II, what then?
Bancel says he is already looking on building out the manufacturing Moderna will need for Phase III and commercial quantities, a project that could consume anywhere from $200 million to $400 million. Once the first clinical data starts to come in, he says, some fast-moving projects could move into Phase III in less than a year. And that will spur more expansion.
Moderna has been working with a variety of groups, including a team from GE, to ramp up new technology to make the manufacturing work more efficient, without getting tripped up by decontamination pitfalls.
“We try to use a lot of equipment that can be reused,” says the CEO, “so that you can go much faster.”
These manufacturing projects in the Boston area have become a plum catch in the economic development field. And for one obvious reason: More jobs. The plan at Moderna now is to shift 100 of their workers to the new site once it becomes operational in early 2018. And they’ll add 100-plus employees once it’s in full swing.
The gamble, and it’s as big as Moderna’s goals, is that they can build a global operation from scratch, with a full suite of technologies and facilities that can keep pace with its ambitions — and, they hope, without any company-ending blowups along the way.
Moderna’s been able to stay on track to that goal, gaining big investors like AstraZeneca along the way who have bought in to the vision. And unlike virtually every other biotech in existence, they built up their extensive infrastructure without a single shred of human clinical data to prove that their drugs actually work in people by spurring patients’ cells to produce drugs.
The data, though, are coming. And Moderna believes it can quickly start to rack up a wide range of trial results, laying out a smorgasbord of data rather than plug along on 2-3 lead proof-of-concept programs.
Moderna is also working to stay out front of mRNA competitors like BioNTech, which coincidentally just struck a major collaboration pact with Genentech. What started out as a biotech race has quickly swelled into a showdown that includes some of the world’s biggest drug developers. Wagers rarely get this big, this early.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.Free Subscription