As a new administration takes hold in Washington, DC, projects launched by the previous administration to secure domestic pharmaceutical production are moving ahead.
On Jan. 15, the US awarded a $69.3 million contract to Continuus Pharmaceuticals for the construction of a facility in Woburn, Massachusetts, that will produce three currently imported medicines. A week later, Civica Rx said it will use government funding to build a $124.5 million sterile injectable drug facility in Petersburg, Virginia.
The grant to Continuus came from the US Department of Defense in conjunction with the US Department of Health and Human Services. It will fund construction of what the firm says will be the first facility to employ continuous manufacturing technology in the end-to-end production of small-molecule active pharmaceutical ingredients (APIs) and finished drugs, including generics and therapies in clinical trials.
Continuus, which grew out of a partnership between the Massachusetts Institute of Technology and Novartis, is among the companies pioneering continuous technologies that promise to be faster and more environmentally friendly than the batch techniques now common in drug production. According to CEO Salvatore Mascia, the firm has developed process systems for customers including Roche and Biogen. He says the new facility will be the first certified to produce under the US Food and Drug Administration’s current good manufacturing practice quality standard using continuous equipment.
Mascia expects the plant to begin producing 100 million doses of three undisclosed drugs in 2023. The company’s modular units can be expanded beyond the products specified in the government contract, he says.
Plans for Civica’s injectable drug facility were first announced last May as part of the debut of Phlow, a partnership that received $354 million from the US government to reshore pharmaceuticals. Phlow has a companion project to build a continuous API production facility at the same site in Petersburg, using technology developed by the Medicines for All initiative at Virginia Commonwealth University, another partner in Phlow. The group also includes Ampac Fine Chemicals, an API producer that operates a former Boehringer Ingelheim plant in Petersburg.
Civica’s plant will include disposable technology in its filling lines, steam sterilization, and automated visual inspection and packaging for the production of 90 million vials and 50 million pre-filled syringes per year. The company was launched in 2018 to secure medicines for health-care system clients in partnership with generic drug makers.
The partners in Phlow, says Civica CEO Martin VanTrieste, “are taking a very long, complex, and fragile supply chain, the result of 20 years of people off-shoring manufacturing, and bringing that into one location to make it a short, simple supply chain from API to precursor to finished product in hospitals.”
VanTrieste says Phlow is waiting to see if the incoming Biden administration will continue to support the establishment of new manufacturing plants dedicated to reshoring drugs.
“I don’t think it will change,” he says, noting that Biden this week issued a “Buy American” executive order. “Pharmaceuticals are part of that executive order,” he says. “I think that both administrations recognize the fact that in the times of national crisis like pandemics, pharmaceuticals are really important for national security.”
Wayne Weiner, who heads the consulting firm Pharmatech Solutions, says the government’s strategy of investing in drug reshoring makes sense. One could question whether investments should be made in wholly new ventures, given the long experience of existing firms, but he says the emphasis on continuous manufacturing, an emerging technology that can make the US more competitive, validates a strategy of investing in the new.
Continuus and the partners that make up Phlow have years of experience going into the new ventures, Weiner adds. “Ampac is a very well respected contract manufacturer,” he says. “I would like to see the government as much as possible taking advantage of companies that really have the demonstrated expertise, the quality systems, and the knowledge of the industry.”