Dive Brief:
- Moderna Therapeutics, the well-funded messenger RNA biotech, on Wednesday gave greater detail into its plans for a new manufacturing plant, announcing an initial investment of $110 million into construction of a 200,000 square foot facility in Norwood, Massachusetts.
- With two programs in the clinic and another nine in preclinical development, Moderna plans to quickly scale up its clinical manufacturing capacity. Construction on the Norwood site will begin in October and is expected to be completed by early 2018.
- One hundred current employees will shift over from Moderna's labs in Cambridge to the new facility and the company said it has plans to hire another 100 more to fully staff up.
Dive Insight:
Moderna has amassed a war chest of roughly $1.4 billion in cash, fueled by two blockbuster funding rounds and a number of partnerships with blue-chip biopharma companies.
Since announcing the initiation of its first clinical study in Europe this past January, Moderna's development work has accelerated. A second clinical program for an infectious disease vaccine candidate recently got started, followed by AstraZeneca and Moderna filing a clinical trial application in Europe to begin testing a third mRNA-based therapy.
An update from the company in July said several other candidates are "on track to enter the clinic" this year.
"With our development pipeline expanding, we need to scale up from our current Cambridge-based GMP clinical supply manufacturing facility," said Moderna CEO Stephane Bancel in a company statement Wednesday.
The new facility will have an initial capacity for 40 "mRNA lots" and eventually will be able to produce over 100 lots per year, according to the company.
Production will be focused on supplying clinical-grade mRNA therapies for toxicology studies, along with Phase 1 and Phase 2 studies. Moderna will be able to manufacture raw materials and APIs at the site, which will also have formulation, fill and finish capacities.
"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 2 clinical study supply across a number of therapeutic areas," said Steve Harbin, senior vice president of manufacturing and operations.
Moderna's hard-driving pace and ambitious goals have led to some staff disruption, however, according to a report from Stat. According to the article, as many as a dozen executives, ranging from the finance head to the R&D chief, have left the company over the past four years, and some have criticized Bancel's intense management style.
With over $1 billion to spend and major pharma partnerships in hand, though, Moderna looks set to press ahead at full-speed.