Fresh off National Resilience's acquisition of a new, state-of-the-art manufacturing site in Ontario, the fledgling CDMO is putting it to the test with a high-profile partnership.
Moderna has tapped National Resilience, founded in November last year, to manufacture mRNA vaccine substance at Resilience’s newly acquired facility in Mississauga, Canada. While sparse on details, Moderna said the substance made at the plant will be delivered globally.
The partnership marks Moderna’s most recent foray into Canada and comes as the biotech faces a vaccine contamination scandal in Japan. In late August, Japanese pharma Takeda, which distributes Moderna’s shot in the country, said it suspended three lots—or about 1.63 million doses—after finding tiny black specks in the vials.
Moderna later revealed that those doses, made at Spain’s Rovi Laboratories, contained pieces of stainless steel that likely resulted from friction between two pieces of metal incorrectly installed in a production line.
Three people have now died after being vaccinated with shots from the contaminated lots, but Takeda and Moderna have maintained that there’s no evidence connecting the deaths to the shots until a formal investigation is carried out. Other public health officials have also cast doubt over the likelihood that the shots led to the deaths.
Up until this point, Moderna has had a relatively clean bill of manufacturing health as it works to rapidly scale up its mRNA production capabilities. Once a little-known biotech with no commercial products prior to the pandemic, Moderna is now angling to supply upward of 1 billion shots by the end of this year and 3 billion by the end of 2022.
With more vaccines comes more sales: The company’s outstanding 2021 orders are now worth about $20 billion.
As part of its growth plans, the Cambridge, Massachusetts-based company announced a month ago that it would work with the Canadian government to bring its drug manufacturing to the Great White North. Moderna’s idea is to eventually build a manufacturing site that would supply Canada with “direct access to rapid pandemic response capabilities," including the company’s two-dose COVID-19 vaccine.
For its part, National Resilience launched last November with $800 million and a mission to strengthen pharma's supply chain. Just months after its founding, the company acquired the 136,000-square-foot commercial plant in Ontario, which had already been given the green light by regulators.
At the time, Resilience said it would look to retain the site’s existing staff, make new hires and invest in facility upgrades. The site is equipped to handle upstream, downstream and aseptic fill-finish work, Resilience said.
On its own growth path, Resilience has also picked up a former Sanofi biomanufacturing site and a former bluebird bio site in North Carolina.