CONTINUUS Awarded $69.3M DoD Grant

CONTINUUS Pharmaceuticals Inc., a producer of small-molecule pharmaceuticals leveraging its Integrated Continuous Manufacturing (ICM) technology, received a $69.3 million U.S. government contract to facilitate domestic production of three vital medicines used to treat critically ill patients, including COVID-19.

The contract, awarded by the Department of Defense (DoD) in conjunction with the Department of Health and Human Services (HHS), will also enable construction of the country's first GMP facility for end-to-end, ICM-driven production of small-molecule drugs, including marketed products, generics, and investigational therapies through all phases of clinical trials and a product's lifecycle. 

CONTINUUS will break ground in Woburn, MA later this month and plans to make the plant fully operational within two years.

The DoD/HHS contract supports rapid and reliable U.S.-based production of high-quality, in-demand medicines. Offshore drug manufacturing can carry risks arising from inconsistent quality, duplicative active pharmaceutical ingredient (API) manufacturing for the same drug at different facilities, and the difficult logistics of quality-control monitoring by the U.S. FDA and other regulatory agencies.

The FDA previously awarded CONTINUUS a contract to help establish a science-based approach to devising regulatory guidelines for continuous drug manufacturing. CONTINUUS' ICM technology reduces drug production time from many months or even years to just a few days, which will help to mitigate shortages of critical drugs. This unique approach also enables manufacturing of multiple drugs in quick succession with lines that can be transported between locations, which the company refers to as "MoP" (Mobile Pharmaceuticals), helping to address supply chain problems in pharmaceutical production.

Watch ICM process

"We are honored to receive this important contract, which recognizes the urgency of ramping up domestic production of critical-care medicines," said Salvatore Mascia, Ph.D., founder and chief executive officer of CONTINUUS Pharmaceuticals. "In addition to streamlining continuous, environmentally friendly, and cost-efficient production of these medicines, this contract will help us build a state-of-the-art facility that will address urgent pharmaceutical supply chain issues, ultimately speeding the delivery of high-quality, affordable medications to patients, while also creating U.S.-based jobs."

"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," said Bayan Takizawa, MD, co-founder and chief business officer of CONTINUUS. "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."