- MaSTherCell S.A. has signed a lease for a 61,000-square-foot plant in Belgium, which the contract manufacturer will build into a manufacturing site for late-stage and commercially-approved cell and gene therapy products, the company said Tuesday.
- The new facility, expected to be operational in early 2021, will triple the company's capacity, according to the parent company, Orgenesis. The building is in the Gosselies Biopark, which also houses MaSTherCell's current plant. Once the new facility is online, the older plant will focus on early and mid-stage clinical products.
- "As a leading CDMO, Masthercell is working hard to address the lack of commercial manufacturing capacity, especially in Europe," Denis Bedoret, president of Masthercell Global, said in a statement.
Masthercell joins the ranks in anticipating a cell and gene therapy boom, as this new plant will greatly expand the CDMO's European presence.
In fact, the expectation that the cell therapy industry will face a global manufacturing shortage is one of the first highlights brought up by Orgenesis in its most recent investor presentation from last October.
While Masthercell added a production wing to its existing Belgian site last December to boost capacity, this longer-term build-out will allow the company to enter into the commercial-stage manufacturing space for these advanced therapies.
The company did not provide any financial figures on cost or investment estimates for the new plant, but one executive said it would add several hundred jobs.
It's a much smaller, albeit similar, version of Thermo Fisher Scientific's recent decision to pay $1.7 billion to acquire Brammer Bio, a contract manufacturer of viral vectors.
Both Thermo Fisher and Masthercell anticipate an uptick in commercial manufacturing stemming from a flurry of R&D activity around cell and gene therapies, with CDMOs standing to win new business.
The CDMOs aren't alone. Already this year, pharma and biotech industry leaders have added exposure to cell and gene therapies with Roche buying Spark Therapeutics and Biogen acquiring Nightstar Therapeutics.
Food and Drug Administration leaders, meanwhile, rolled out a plan in January to keep pace with the industry, focused on expanding its review staff, issuing more guidance and stepping up enforcement actions.
Orgenesis is a small but growing business based in Germantown, Maryland. The company had revenues of less than $20 million in 2018, which was an 85% increase over a year ago.
Those revenues have been driven by MasTherCell, which it acquired in March 2015. Last year, the CDMO business gained several customers last year, primarily with a clinical focus, including Iovance Biotherapeutics, Zelluna Immunotherapy and ReNeuron.
In Russian nesting doll style, Orgenesis is the parent company of Masthercell Global, which operates its CDMO platform by overseeing a range of subsidiaries including MaSTherCell S.A. in Belgium and other CDMOs based in Israel, South Korea and the U.S.