Massachusetts Institute of Technology (MIT) spinout Continuus Pharmaceuticals is joining the push to bring drug manufacturing stateside, and it's tapped some cutting-edge tech for the job.
Armed with a $69.3 million government contract, Continuus will build out what it says is the country's first FDA approved end-to-end manufacturing facility leveraging its integrated continuous manufacturing (ICM) technology. The plant will be equipped to handle production, from active pharmaceutical ingredients (APIs) to finished drugs, for marketed products, generics and therapies still in clinical testing, the company said.
The contract, awarded by the U.S. Department of Defense and the U.S. Department of Health and Human Services, will also see Continuus use its ICM tech at the new facility to onshore production of three critical meds used to treat patients in intensive care, including those with COVID-19. The company can't disclose which drugs are covered, but, once the plant comes online, the company aims to crank out 100 million doses per year, Salvatore Mascia, Ph.D., founder and CEO of the company, said in an interview.
Continuus plans to hire more than 50 employees to fill out the roughly 50,000-square-foot facility, set for construction in the company's hometown of Woburn, Massachusetts, Mascia said. The company will kick off the building project this month, with a view to get the plant up and running within the next two years.
The deal follows concerted efforts to ween the U.S. off of foreign imports of critical medicines—an issue drawn into sharp focus last year by the COVID-19 pandemic. Since then, a number of companies, including Eastman Kodak, Phlow Corp and Civica Rx, have chipped in.
That's part and parcel of Continuus' mission, co-founder Bayan Takizawa, M.D., said in a release. "Beyond addressing national security needs in obtaining critical-care medicines from overseas, we will work with hospitals and pharmacies to ensure that other key drugs, such as epinephrine and ciprofloxacin, are never again in shortage.
"The impact on the pharmaceutical industry will also be significant, as our technology eliminates the typical delays associated with scale-up, allowing companies to accelerate development of small-molecule drugs for faster delivery to patients in need," he added.
Central to Continuus' contract is its ICM tech, born out of a multiyear continuous manufacturing collaboration between MIT and pharma juggernaut Novartis. The platform, as Mascia sees it, has three big advantages over traditional batch manufacturing: speed, quality and cost.
Continuus' ICM platform reduces production time from months or even years in some cases to just days, Mascia said. The company is also able to monitor the quality of its production in real time, which means it can catch potential problems as they happen, stepping in to divert small portions of a product rather than scrapping an entire batch.
Continuous manufacturing also offers a clear flexibility edge, Mascia figures. The company can dial up or dial down production as needed to avoid variability during clinical manufacturing. It can also accelerate that clinical trial manufacturing to help companies get their products to market faster, as well as track demand for a newly launched drugs in real time to produce as much or as little as a company needs.
Meanwhile, the small footprint of these continuous manufacturing lines means they can be easily transported between facilities, Mascia said—something that he thinks will be disruptive to the industry. Those lines can be placed into pods—essentially a "plant in a box"—which can then be moved to other facilities, a factor that could be extremely useful in the event of a pandemic or natural disaster when manufacturing may need to be diverted from a specific plant.
That capability, which Continuus refers to as Mobile Pharmaceuticals (MoP), has the potential to redefine contract manufacturing, especially for specialty drug companies, which typically have to transfer specific steps, skill sets and more to contract manufacturers' facilities when they want to outsource production. Using MoP, Continuus thinks it could integrate that manufacturing process directly into the facilities of Big Pharmas such as Pfizer and Roche, Mascia said.
"End-to-end continuous manufacturing is going to be the next disruptive item for the industry," Mascia said, noting that it will streamline distribution as well as manufacturing. "We will be able to eliminate the middle man and the large distributor and go straight to the pharmacy." That move, in turn, will help reduce shortages and potentially even cut drug prices, he said.
This isn't the first time the company has leveraged ICM to explore onshore production, either. Back in 2016, Continuus snared a $4.4 million contract from the FDA to construct an ICM pilot plant and perform engineering runs on its tech to demonstrate how end-to-end continuous manufacturing could improve drug quality as well as to develop a science- and risk-based approach for future regulatory guidelines concerning the process.